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Showing 20 of 28810 trials
"Serratus Anterior Plane Block" Versus "Serratus Posterior Superior Plane Intercostal Plane Block" for Patients Undergoing Breast Surgery
NCT06711549
Not yet recruiting
Conditions Pain, Postoperative, Breast Cancer, Anes...
Phase NA
Enrollment 46
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Serratus Posterior Superior Plane Intercostal Plane block
  • Serratus Anterior Plane block

Primary Outcomes

  • Pain at 0 hours after surgery
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2024-11-20
Completion: 2026-11-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 46 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Ospedale di Camposampiero
Collaborators: Azienda Ulss 6 Euganea
Contact Information
Study Contact:
Valentina Scaduto
3272217089
valentinascaduto@yahoo.com
Interventions
  • Serratus Posterior Superior Plane Intercostal Plane block
  • Serratus Anterior Plane block
Eligibility Criteria
Inclusion Criteria: * Adult Patient ( \> 18 years) * Informed consent * American Society of Anaesthesiologis Phisical Status I to III * Patients undergoing for mastectomy with sentinel lynphnode byopsy/axillary clearence Exclusion Criteria: * Pregnant women * Allergy to any drug present in the protocol
Radon Asthma Intervention Trial
NCT06706336
Not yet recruiting
Conditions Asthma
Phase NA
Enrollment 180
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • radon mitigation system
  • Sham (No Treatment)

Primary Outcomes

  • Asthma symptoms
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-06-01
Completion: 2030-04-01
Eligibility
Age: 5 Years
Sex: ALL
Volunteers: false
Enrollment: 180 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Boston Children's Hospital
Principal Investigators:
  • Wanda Phipatanakul (PRINCIPAL_INVESTIGATOR) - Boston Children's Hospital
Contact Information
Study Contact:
Wanda Phipatanakul
857-218-5336
Asthma@childrens.harvard.edu
Interventions
  • radon mitigation system
  • Sham (No Treatment)
Eligibility Criteria
1. Have physician-diagnosed asthma at least 1 year prior to the screening visit 2. Have evidence of uncontrolled disease as defined by at least one of the following: Use of an asthma medication during the prior 12 months, report of asthma symptoms over the prior 12 months (wheezing/whistling in the chest)(3) OR One or more asthma-related hospitalization, emergency room visit OR Unscheduled clinic or urgent care facility visit resulting in a burst of systemic steroids (3 days or more of prednisone or equivalent; 1 or more doses of dexamethasone) in the previous 12 months Exclusion Criteria 1. Not residing at the household for at least 5 days a week or family planning to move from the current home within the next twelve months, or homes with active radon mitigation systems (if home uses a HEPA filter air purifier, family must agree to disable the purifier for 28 days prior to randomization). 2. Lung disease, other than asthma, that requires daily medication (inflammatory diseases, chronic lung diseases aside from asthma, congenital cardiopulmonary conditions requiring medication or surgical treatment), 3. Homes with active HEPA filters will be excluded (even though the role of HEPA filters on radon and radon particles s is expected to be minimum and other exposures can be adjust for in the analysis) 4. Cardiovascular disease that requires daily medication, excluding hypertension 5. Taking a beta-blocker 6. Currently receiving unstable level of Immunotherapy (allergy shots) 7. Coordinator/PI judgment 8. Inability to perform lung function testing 9. Intake of abuse drugs or alcohol, have psychiatric disorders or severe mental disability that interferes with answering questions or following instructions.
Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA)
NCT06705764
Recruiting
Conditions Severe Asthma
Phase PHASE4
Enrollment 100
Locations 2 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Tezepelumab
  • Placebo

Primary Outcomes

  • Proportion of patients who have moderate and severe exacerbations of asthma
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2026-05-11
Completion: 2026-11
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Alberta
Collaborators: AstraZeneca
Principal Investigators:
  • Irvin Mayers, MD (PRINCIPAL_INVESTIGATOR) - University of Alberta
Contact Information
Study Contact:
Hannah Anstruther, RRT
7804923741
hannahanstruther@ualberta.ca
Amy May, RRT
7804923741
amy.may@ualberta.ca
Interventions
  • Tezepelumab
  • Placebo
Study Locations (2 sites)
University of Alberta, Edmonton, Alberta T6G 2G3 Canada
Sturgeon Community Hospital, St. Albert, Alberta T8N6C4 Canada
Eligibility Criteria
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures 2. Female and/or male aged 18 to 55 years 3. History of physician-diagnosed asthma 4. All subjects will have been prescribed high dose inhaled corticosteroid (\> 500 ug fluticasone propionate dry powder formulation equivalents total daily dose. See Appendix C) plus at least one second controller (LABA, LAMA or LTRA) for at least 3 months prior to enrolment. 5. Documented history of at least one moderate or severe asthma exacerbation in the past 12 months 6. Negative pregnancy test (urine or serum) for female subjects of childbearing potential. 7. Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of study drug/matching placebo to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used. 8. Subjects who are blood donors should not donate blood during the study and for 3 months following their last dose of study drug. 9. Subject willing and able to comply with study procedures Exclusion Criteria: 1. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site) 2. Previous enrolment in the present study 3. Participation in another clinical study with an investigational product during the last 6 months 4. Patients with a known hypersensitivity to Tezepelumab or any of the excipients of the product. 5. Patients who are admitted to hospital at screening. 6. Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening. 7. Known to have tested positive for human immunodeficiency virus 8. Current smokers with a smoking history of \> 10 pack-years. Current smokers with a smoking history of \< 10 pack-years are permitted . Ex-smokers should not have a smoking history \> 10 pack-years at screening. Participants who use e-cigarettes will also be excluded from the study. 9. Known history of drug or alcohol abuse within 1 year of screening 10. Any concomitant medications that are known to be associated with Torsades de Pointes or potent inducers of cytochrome P450 3A4 (CYP3A4). 11. History of QT prolongation associated with other medications that required discontinuation of that medication. 12. Congenital long QT syndrome. 13. Creatinine clearance \<50 ml/min (calculated by Cockcroft-Gault formula, reference Appendix G). 14. For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding. 15. History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.
Oral Intake of Mg in Controlled Asthmatic Patients
NCT06721247
Active, positions filled
Conditions Bronchial Asthma
Phase PHASE2, PHASE3
Enrollment 166
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Magnesium
  • ICS+LABA

Primary Outcomes

  • improvement in the degree of asthma control
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Status: Active, positions filled
Start Date: 2024-11-02
Completion: 2025-11-02
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 166 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Zagazig University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Magnesium
  • ICS+LABA
Study Locations (1 sites)
Faculty of Medicine Zagazig University, Zagazig, 44511 Egypt
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years. * Stable controlled asthmatic patients . Exclusion Criteria: * Medical conditions and disorders (such as chronic kidney disease, diabetes mellitus, cardiac disease, alcoholism, diarrhea, and pregnancy). * Any treatment which might affect the absorption or excretion of Mg2+ including digoxin, diuretics, and calcium-containing medications. * Patients in asthma exacerbations .
Effects of a Healthy Nordic Diet on Atherosclerosis in Patients with Coronary Heart Disease
NCT06701968
Recruiting
Conditions Coronary Disease, Coronary Arteriosclero...
Phase NA
Enrollment 150
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Healthy Nordic Diet
  • Usual Care

Primary Outcomes

  • Change in coronary plaque volume
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-03-20
Completion: 2031-12-30
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: false
Enrollment: 150 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Uppsala University
Collaborators: Falu Hospital
Principal Investigators:
  • Ulf Risérus, MMED, PHD (PRINCIPAL_INVESTIGATOR) - Uppsala University
Contact Information
Study Contact:
Emil Hagström, MD, PHD
46184710000
emil.hagstrom@ucr.uu.se
Fredrik Rosqvist, PHD
fredrik.rosqvist@uu.se
Interventions
  • Healthy Nordic Diet
  • Usual Care
Study Locations (1 sites)
Cardiology clinic, Uppsala university hospital, Uppsala, Sweden
Eligibility Criteria
Inclusion Criteria: * Men and women * Diagnosis with MI from 2 weeks after diagnosis and with maximum 6 months after diagnosis * Diagnosis with CCS (e.g. stable angina pectoris) * Ages 50 to 80 years * BMI 25-40. Exclusion Criteria: * Severe heart failure (NYHA classes III, IV) * Alcohol intake \>20g/day * Unwillingness to follow a new prescribed diet for 18 months * Other diseases implying a short estimated life expectancy (e.g. severe malignant or kidney or liver disease, as judged by consenting physician).
Low Intraocular Pressure Cataract Surgery With Zeiss Quatera in Glaucoma Patients
NCT06712758
Recruiting
Conditions Cataract, Glaucoma
Phase Not Applicable
Enrollment 10
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Complication rate during cataract surgery
Interested in this trial?
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Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2024-11-12
Completion: 2025-12-31
Eligibility
Age: No restriction
Sex: ALL
Volunteers: false
Enrollment: 10 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Visionair Oogzorg
Principal Investigators:
  • Koen Willekens (PRINCIPAL_INVESTIGATOR) - Visionair Oogzorg
Contact Information
Study Contact:
Koen Willekens, Prof
003214808311
kw@visionairoogzorg.be
Sien Boons
003216715634
sb@visionairoogzorg.be
Interventions
N/A
Study Locations (1 sites)
Visionair Oogzorg, Geel, 2400 Belgium
Eligibility Criteria
Inclusion Criteria: * Patients diagnosed with glaucoma that are diagnosed with age-related cataract Exclusion Criteria: * Unwilling to sign informed consent * Functionally monophtalmic patient * Endothelial dystrophy * Active uveitis * Known corticosteroid responder * Presence of uncontrolled systemic disease
Radiotherapy Followed by Chemotherapy Combined With Toripalimab in Local Advanced HR-positive,HER2-negative BC.
NCT06705127
Recruiting
Conditions HR-positive,HER2-negative Breast Cancer
Phase PHASE2
Enrollment 30
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • TORIPALIMAB INJECTION(JS001 )
  • Stereotactic Body Radiation Therapy (SBRT)

Primary Outcomes

  • Pathologic complete response(pCR)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-07-01
Completion: 2028-07-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: First Affiliated Hospital of Zhejiang University
Principal Investigators:
  • Peifen Fu, MD (PRINCIPAL_INVESTIGATOR) - Zhejiang University
  • Senxiang Yan, MD (PRINCIPAL_INVESTIGATOR) - Zhejiang University
Contact Information
Study Contact:
Peifen Fu, MD
0571-87236852
fupeifen@zju.edu.cn
Interventions
  • TORIPALIMAB INJECTION(JS001 )
  • Stereotactic Body Radiation Therapy (SBRT)
Study Locations (1 sites)
the First Affiliated Hospital,Zhejiang University School of Medicine, Hangzhou, Zhejiang 310003 China
Eligibility Criteria
Inclusion Criteria: 1. Age 18-75 years old, gender is not limited; 2. Histologically or pathologically confirmed non-specific invasive ductal carcinoma, histologically grade3, ER≥1%, HER2 negative, Ki-67\>20%; 3. T1c-T2(≥2cm)N1-2M0 or T3-4cN0-2M0; 4. No previous treatment; 5. ECOG PS 0-1 score; 6. The subject or legal representative has been informed of the nature of the study, understands the protocol, is able to guarantee compliance, and signs the informed consent Exclusion Criteria: 1. Those who are known to be allergic to recombinant humanized antiPD-1 monoclonal antibody drugs and their components; 2. Currently participating in and receiving other research treatment; 3. Previously received systematic treatment for breast cancer, including systematic chemotherapy, targeted therapy, immunotherapy, etc.; 4. Remote metastatic lesions of breast cancer were confirmed by imaging or pathology; 5. Patients with active tuberculosis (TB) who are receiving anti-TB therapy or have received anti-TB therapy within 1 year prior to screening; 6. Uncontrolled or symptomatic hypercalcemia (\&gt; 1.5mmol/L calcium ion or calcium \&gt; 12mg/dL or corrected serum \&gt; ULN); 7. Clinically uncontrolled active infections, including but not limited to acute pneumonia; 8. Uncontrollable major seizures or superior vena cava syndrome; 9. previous or current co-occurrence of other malignant tumors (except for non-melanoma skin basal cell carcinoma or squamous cell carcinoma, breast/cervical carcinoma in situ, superficial bladder carcinoma and other in situ cancers that have been treated radically and have no evidence of disease recurrence); 10. Have a history of interstitial pneumonia, idiopathic pulmonary fibrosis, institutional pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, chest CT screening found evidence of active pneumonia or other moderate to severe lung diseases that seriously affect lung function; 11. Known human immunodeficiency virus (HIV) infection (known HIV antibody positive); 12. Severe cardiovascular disease, such as New York Heart Association (NYHA) grade 2 or higher heart failure, unstable angina, unstable arrhythmia, myocardial infarction or cerebrovascular accident within the first 6 months of enrollment; 13. received systemic immunosuppressive drugs (i.e. use of corticosteroids or immunosuppressive drugs) for any active autoimmune disease within 2 years prior to study initiation; 14. Received live virus vaccine within 4 weeks prior to study initiation; 15. Patients who have previously received allogeneic stem cells or parenchymal organ transplants; 16. Pregnant or lactating women or women who have the possibility of becoming pregnant have tested positive for pregnancy before the first drug use, and patients who are fertile but do not want to take contraceptive measures or their sexual partners do not want to take contraceptive measures 17. Any other clinically significant illness or condition that the investigator believes could affect adherence to the protocol (such as a history of mental illness or substance abuse), prevent the patient from benefiting from the clinical study, or prevent the patient from signing informed consent (such as drug use and substance abuse), or make participation in the clinical study inappropriate (including but not limited to: Abnormal laboratory results, clinical active diverticulitis, abdominal abscess, intestinal obstruction, and peritoneal metastases).
App-based Diabetes Management and Community-based Interventions
NCT06688903
Recruiting
Conditions Diabetes Mellitus Type 2
Phase NA
Enrollment 150
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • App-based diabetes management and community-based health coaching

Primary Outcomes

  • HbA1c
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-01-06
Completion: 2026-06-30
Eligibility
Age: 21 Years
Sex: ALL
Volunteers: false
Enrollment: 150 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Singapore General Hospital
Contact Information
Study Contact:
Research coordinators
6562223222
empower@singhealth.com.sg
Interventions
  • App-based diabetes management and community-based health coaching
Study Locations (2 sites)
Singapore General Hospital, Singapore, Singapore
Singapore General Hospital, Singapore, Singapore
Eligibility Criteria
Inclusion Criteria: * Aged 21 years and above * Having been diagnosed with type 2 diabetes mellitus * Having most recent HbA1c ≥ 6.5% * Physically able to exercise * Able to read, write, and converse in English * Able to comply with study procedures Exclusion Criteria: * Requiring assistance with basic activities of daily living (BADL) * Have planned major operation or surgical procedure within 6 months from the time of recruitment * Current pregnant or lactating
A Study of Language Interpretation Solutions for People With Breast Cancer
NCT06721065
Recruiting
Conditions Breast Cancer, Breast Cancer Stage II, B...
Phase NA
Enrollment 700
Locations 8 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Remote Simultaneous Medical Interpreting/RSMI
  • Remote Consecutive Medical Interpreting/RCMI
  • Remote Consecutive Video Medical Interpreting/RCVI

Primary Outcomes

  • Number of interpretation errors
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-12-02
Completion: 2029-12-02
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 700 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Memorial Sloan Kettering Cancer Center
Principal Investigators:
  • Francesca Gany, MD, MS (PRINCIPAL_INVESTIGATOR) - Memorial Sloan Kettering Cancer Center
Contact Information
Study Contact:
Francesca Gany, MD, MS
646-888-8054
ganyf@mskcc.org
Lisa Diamond, MD
646-888-8061
diamondl@mskcc.org
Interventions
  • Remote Simultaneous Medical Interpreting/RSMI
  • Remote Consecutive Medical Interpreting/RCMI
  • Remote Consecutive Video Medical Interpreting/RCVI
Study Locations (8 sites)
Memorial Sloan Kettering Basking Ridge (Consent Only), Basking Ridge, New Jersey 07920 United States
Memorial Sloan Kettering Monmouth (Consent Only), Middletown, New Jersey 07748 United States
Memorial Sloan Kettering Bergen (Consent Only), Montvale, New Jersey 07645 United States
Memorial Sloan Kettering Suffolk- Commack (Consent Only), Commack, New York 11725 United States
Memorial Sloan Kettering Westchester (Consent Only), Harrison, New York 10604 United States
Memorial Sloan Kettering at Ralph Lauren Center (All Protocol Activities), New York, New York 10035 United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York 10065 United States
Memorial Sloan Kettering Nassau (All Protocol Activities), Rockville Centre, New York 11553 United States
Eligibility Criteria
Inclusion Criteria: Phase I Patients * Age \>=18 years (per EMR) * Preferred language for healthcare is Spanish or Mandarin (per self-report) * Limited English Proficient; cannot speak English "very well" (per self-report) * Diagnosis of breast cancer or gastrointestinal (per EMR) * Will be visiting MSK oncology teams for the first or second appointment (per EMR) * Agrees to be audio-recorded (per self-report) Phase 1 Providers * Breast or gastrointestinal cancer provider who sees patients (e.g., breast or gastrointestinal oncologists, advanced practice providers, and/or nurses) * Does not speak Spanish and/or Mandarin; providers who speak one language and not the other may participate (e.g., speaks Spanish but not Mandarin) (per self-report) * Agrees to be audio-record (per self-report) Phase 2 (clinic staff only; patient participants will be drawn from Phase 1) * Is a staff member who works/worked in one of the study clinic sites during the period of Phase 1 RCT study activities * Agrees to be audio-recorded (per self-report) Exclusion Criteria: Phase 1 Patients * Has significant psychiatric disturbance (i.e., acute psychiatric symptoms) sufficient to preclude completion of the assessments, interviews, or informed consent (per EMR, patient's care team, or study team) * Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection (per EMR, patients, care team, or study team) Phase I Providers * None Phase 2 (clinic staff only; Phase 1 patient participants follow above criteria) * None
A Phase IIb Study of 610 in Participants With Severe Eosinophilic Asthma
NCT06680947
Active, positions filled
Conditions Asthma
Phase PHASE2
Enrollment 225
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • 610
  • 610
  • Placebo

Primary Outcomes

  • Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 52
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2024-12-20
Completion: 2027-09
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 225 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Principal Investigators:
  • Min Zhang, Doctor (PRINCIPAL_INVESTIGATOR) - Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • 610
  • 610
  • Placebo
Study Locations (1 sites)
Shanghai General Hospital, Shanghai, Shanghai Municipality China
Eligibility Criteria
Inclusion Criteria: * 1\. Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study. * 2\. Female and male aged 18 to 75 years. * 3\. Diagnosed with asthma for ≥12 months that meet GINA. * 4\. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening. * 5\. Documented history of ≥ 1 moderate exacerbations within 12 months prior to screening. * 6\. Asthma Control Questionnaire question version (ACQ) score ≥1.5 at the screening visit and the randomization visit. Exclusion Criteria: * 1\. Presence of a known pre-existing, clinically important lung condition other than Asthma. * 2\. Severe asthma exacerbation within 4 weeks prior to randomization. * 3\. Subjects with any eosinophilic diseases other than asthma. * 4\. Known, pre-existing severe or clinically significant cardiovascular disease. * 5\. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment. * 6\. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening. * 7\. Subjects with allergy/intolerance to a monoclonal antibody.
Treating Loneliness In The Older Adult With Depression With tDCS
NCT06658795
Recruiting
Conditions Major Depressive Disorder, Loneliness
Phase NA
Enrollment 180
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Transcranial direct current stimulation (tDCS) on the Left DLPFC
  • Transcranial direct current stimulation (tDCS) on the right VLPFC
  • Sham stimulation group

Primary Outcomes

  • Change in loneliness levels from baseline measured by the UCLA Loneliness Scale from baseline
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-10-29
Completion: 2026-12-30
Eligibility
Age: 60 Years
Sex: ALL
Volunteers: true
Enrollment: 180 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Guangzhou Psychiatric Hospital
Collaborators: The University of Hong Kong
Contact Information
Study Contact:
Kangguang Lin, PhD; MD
8613560360144
klin@gzhmu.edu.cn
Robin Shao, PhD
James0828@hotmail.com
Interventions
  • Transcranial direct current stimulation (tDCS) on the Left DLPFC
  • Transcranial direct current stimulation (tDCS) on the right VLPFC
  • Sham stimulation group
Study Locations (1 sites)
Guangzhou Brain Hospital, Guangzhou, Guangdong 510370 China
Eligibility Criteria
Inclusion Criteria: * High loneliness (UCLA Loneliness Scale \> 43). * Diagnosis of major depressive disorder confirmed by the Structured Clinical Interview for DSM-5 Disorders. * absence of suicidal ideation (Hamilton Depression Scale item 3 score ≤ 1). Exclusion Criteria: * Severe neurological diseases. * Bipolar disorder, schizophrenia, addiction, or impulse control disorders. * Contraindications for tDCS or MRI (e.g., metal implants). * Presence of suicidal ideation.
Middle-aged and Older Adults with Hypertension in Rural Communities
NCT06666361
Recruiting
Conditions Hypertension
Phase NA
Enrollment 160
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Experimental Group
  • control group

Primary Outcomes

  • 1.To explore the effectiveness of mobile health(m-health) interventions on the health literacy of study participants. 2.To explore the effectiveness of mobile health(m-health) interventions on the health promotion behaviors of study participants.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-12-07
Completion: 2025-12-31
Eligibility
Age: 45 Years
Sex: ALL
Volunteers: false
Enrollment: 160 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Chimei Medical Center
Principal Investigators:
  • Su.Chiu Hsiao (PRINCIPAL_INVESTIGATOR) - Chi Mei Medical Center,Liouying Director Nursing Department
Contact Information
Study Contact:
Man-Ting Cheng
+886 961062509
hate6699@gmail.com
Interventions
  • Experimental Group
  • control group
Study Locations (1 sites)
Chi Mei Hospital, Liouying, Tainan, Taiwan 73657 Taiwan
Eligibility Criteria
Inclusion Criteria: 1. Diagnosed with hypertension for one year or more (including) and controlled with medication (systolic blood pressure ≥ 130 mmHg and diastolic blood pressure ≥ 80 mmHg). 2. Aware hypertensive patients aged ≥ 45 years with the ability to read and write. 3. Able to take medication independently. 4. Own a smartphone and are able to use it, and are willing to receive text messages (TxtM) or mobile health interventions (m-Health). 5. Agree to participate in the study. Exclusion Criteria: 1. Have cognitive impairments or mental disorders. 2. CCI (Charlson Comorbidity Index) score ≥ 3.
Effects of Intranasal Ketamine on Depression and Anxiety in Palliative Care Cancer Patients
NCT06665568
Not yet recruiting
Conditions Depressive Symptoms Mild to Moderate in ...
Phase EARLY_PHASE1
Enrollment 100
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Intranasal ketamine hydrochloride

Primary Outcomes

  • Change in depressive symptoms assessed by the MADRS
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: Not yet recruiting
Start Date: 2025-04
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Zurich
Contact Information
Study Contact:
Caroline Hertler, MD, PhD
+41 43 253 95 59
caroline.hertler@usz.ch
David Blum, MD, PhD
+41 79 154 87 47
david.blum@usz.ch
Interventions
  • Intranasal ketamine hydrochloride
Study Locations (1 sites)
University Hospital Zurich, Zurich, Canton of Zurich 8091 Switzerland
Eligibility Criteria
Inclusion Criteria (patients): * Informed Consent as documented by signature; * HADS total score of 6 or greater; * Age 18 years or older; * Progressive cancer diagnosis (estimated life expectancy 24 months or more) * Able to attend study visits; * Ability to speak and understand German; Exclusion Criteria (patients): * Clinician assessed cognitive impairment; * Clinician assessed alcohol or drug abuse; * Pregnancy or breast-feeding; * Severe hypertension (greater than 200/120 mmHg); * Anamnestic mood disorder (major depressive disorder, treatment resistant depression, etc.); * Suicidality (C-SSRS total score of "low" or less); * Weight less than 39 kg, greater than 170 kg; * Angina pectoris or myocardial infarction in the last 6 months; * Lifetime abuse or dependence on ketamine or phencyclidine; * Substance abuse or dependence in the 6 months before screen; * Nasal obstructions or history of nasal surgery. * Serious health risk caused by increased blood pressure or intracranial pressure: * Known aneurysmal vascular disease (including intracranial, thoracic or abdominal aortic or peripheral arterial vessels); * Known history of intracerebral hemorrhage; * Recent (within 6 weeks) cardiovascular event including myocardial infarction (MI). Inclusion criteria (caregivers): * Informed Consent as documented by signature; * Age 18 years or older; * Able to attend study visits; * Ability to speak and understand German. Exclusion criteria (caregivers): \- None.
Implementation of a Peer Leader-facilitated Dyadic Intervention
NCT06643806
Not yet recruiting
Conditions Cardiovascular Diseases, Type 2 Diabetes...
Phase NA
Enrollment 80
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • CHAI dyad study

Primary Outcomes

  • Risk of CVD
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2025-02
Completion: 2025-07
Eligibility
Age: 20 Years
Sex: ALL
Volunteers: true
Enrollment: 80 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Rutgers, The State University of New Jersey
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Principal Investigators:
  • Karen T D'Alonzo, PhD (PRINCIPAL_INVESTIGATOR) - Rutgers, The State University of New Jersey
Contact Information
Study Contact:
Karen T D'Alonzo, PhD
(908)-963-7064
kdalonzo@sn.rutgers.edu
Shailja Mathur, M.S., M.Ed.,
908-692-5823
mathur@njaes.rutgers.edu
Interventions
  • CHAI dyad study
Eligibility Criteria
Inclusion Criteria: * community-dwelling first generation Asian Indian (AI) immigrants (in marital dyads) between the ages of 18-70 years of age who can read and write English and are technology literate. Exclusion Criteria: * AIs not in a marital dyad, those below the age of 20 or above 70 years or those born in the US or visiting the US from India.
Lithium for Prevention of Cognitive Declining in Mood Illnesses
NCT06662526
Not yet recruiting
Conditions Dementia, Bipolar Disorder (BD), Depress...
Phase PHASE4
Enrollment 250
Locations 2 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Trace lithium dose plus treatment as usual
  • Placebo pill plus treatment as usual

Primary Outcomes

  • Incidence of MCI
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Not yet recruiting
Start Date: 2024-11-01
Completion: 2030-11-01
Eligibility
Age: 55 Years
Sex: ALL
Volunteers: false
Enrollment: 250 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Chile
Contact Information
Study Contact:
Paul A. Vohringer, M.D., M.Sc., M.P.H.
+56 966011954
pvohringer@gmail.com
Barbara A. Palma, M.D., P.h.D
+56 990783224
dra.bpalmam@gmail.com
Interventions
  • Trace lithium dose plus treatment as usual
  • Placebo pill plus treatment as usual
Study Locations (2 sites)
Instituto Psiquiátrico Dr. José Horwitz Barak, Santiago, Santiago Metropolitan 8431621 Chile
Psychiatric Institute Dr. José Horwitz Barak, Santiago, Santiago Metropolitan 8431621 Chile
Eligibility Criteria
Inclusion Criteria: 1. Age 55-70. 2. DSM-5 diagnosis of major depressive disorder or bipolar disorder (types I or II), current or lifetime. 3. Prior to participation in this study, each subject must sign an informed consent. Exclusion Criteria: 1. Current mood treatment with lithium. 2. Alcohol dependency within the past month. 3. Current serious unstable medical conditions or history of medical illness that would contraindicate a trial of lithium. 4. Current or past severe kidney disease or baseline creatinine \> 1.5 mg/dl. 5. Active suicidal ideation with plan and intent (Columbia Suicide Severity Rating Scale Screen Version (C-SSRS Screen) \> 3 points). 6. Current or past severe thyroid disease or baseline TSH \>5.0 uUI/dl. 7. Current diagnosis of dementia of any kind.
Planning Grant for TOPS for Breast Cancer Survivors
NCT06658912
Not yet recruiting
Conditions Breast Cancer, Weight Loss
Phase NA
Enrollment 25
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • TOPS Classes

Primary Outcomes

  • Number of invitations sent through the electronic health record to get 25 individuals consented to the study
  • Percentage of TOPS group session attendance
  • Number of participants who stay in the study
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-06-01
Completion: 2027-09-30
Eligibility
Age: 21 Years
Sex: FEMALE
Volunteers: false
Enrollment: 25 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Duke University
Principal Investigators:
  • Nia S Mitchell, MD (PRINCIPAL_INVESTIGATOR) - Duke University
Contact Information
Study Contact:
Nia S Mitchell, MD
833-637-8839
nia.s.mitchell@duke.edu
Interventions
  • TOPS Classes
Study Locations (1 sites)
Duke University, Durham, North Carolina 27710 United States
Eligibility Criteria
Aim 2 Inclusion Criteria: * women diagnosed with breast cancer with BMI ≥ 25 kg/m2 after completion of primary therapy (surgery, radiation, adjuvant or neo-adjuvant chemotherapy). Aim 2 Exclusion Criteria: * Those whose oncology providers do not agree with their participation in a weight loss program * History of Type II Diabetes Mellitus * those participating in another weight loss program * those taking a weight loss medication * those without smart phones or internet connections or the ability to attend meetings via Zoom
Effects of Balloon-blowing Exercises in 90/90 Bridge Position With a Ball on Pulmonary Function Among Asthmatic Patients
NCT06660537
Recruiting
Conditions Asthma
Phase NA
Enrollment 41
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Balloon-blowing exercises in 90/90 bridge position with a ball.
  • Buteyko breathing exercises management

Primary Outcomes

  • pulmonary function test
  • Dyspnea
  • Quality of life of patient
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-08-15
Completion: 2025-02-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 41 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Foundation University Islamabad
Contact Information
Study Contact:
Anam Anwar, MS-CPT*
0333-5226687
anam.anwar102@gmail.com
Interventions
  • Balloon-blowing exercises in 90/90 bridge position with a ball.
  • Buteyko breathing exercises management
Study Locations (1 sites)
Foundation University College of Physical Therapy, Rawalpindi, Punjab Province 46000 Pakistan
Eligibility Criteria
Inclusion Criteria: * Adults: aged (18-59 years) * Gender: Both male and females * Grade1- Grade 4 on Modified MRC dyspnea scale * Asthma severity ( level 1 mild intermediate, levell 2 mild persistent) Exclusion criteria: * Level 3 and above asthmatics or status asthmatics. * Any congenital deformities of chest wall/ Heart/ Lungs. * Demonstrated neuromuscular or neurological deficit/ chest wall deformity. * Cardiopulmonary diseases including coronary artery disease(CAD), Pulmonary HTN, ------Aortic Stenosis, regurgitation, etc. * Any Autoimmune disease with manifestations of Chest wall/ heart/ Lungs. * Any recent cardiothoracic or abdominal surgery or sternotomy. * Recent history of the blunt chest wall or abdominal trauma. * Unstable hemodynamic parameters (arterial pressure \>140mmhg systolic and \>90mmhg for diastolic). * Pregnancy
Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans
NCT06671977
Recruiting
Conditions Major Depression Disorder, Depression
Phase PHASE1
Enrollment 60
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • DMT-Medium Dose
  • DMT-Low Dose
  • THC-Medium Dose
  • THC-Low Dose

Primary Outcomes

  • Safety of Physiological indices
  • Psychedelic Effects
  • Psychotomimetic Effects
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2025-03-14
Completion: 2027-12-01
Eligibility
Age: 21 Years
Sex: ALL
Volunteers: true
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Deepak C. D'Souza
Principal Investigators:
  • Deepak D'Souza, MD (PRINCIPAL_INVESTIGATOR) - Yale University
Contact Information
Study Contact:
Deepak C D'Souza, MD
(203) 932-5711
deepak.dsouza@yale.edu
Interventions
  • DMT-Medium Dose
  • DMT-Low Dose
  • THC-Medium Dose
  • THC-Low Dose
Study Locations (1 sites)
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine,, West Haven, Connecticut 06516 United States
Eligibility Criteria
Some Common Inclusion Criteria: 1. Males and females 2. Age 21 to 65 years 3. Body mass index between 18-35 kg/m2 4. Willing to refrain from taking any medications not approved by the study physician 5. Willing to refrain from using street drugs and alcohol 6. Negative urine drug screen 7. Willing and able to abstain from smoking throughout each test session 8. Women who are of child-bearing potential (WOCBP) and sexually active must be willing to practice an effective means of birth control 9. Willing not to drive to and from the testing session Some Inclusion Criteria for Subjects with MDD: 1. Diagnosed with Major Depressive Disorder (MDD) 2. Unsatisfactory response to antidepressants 3. Engaged in treatment for depression with a clinician and willing to continue treatment for the duration of the study 4. Not engaged in treatment 5. Consent to allow the research team to communicate with mental health provider. 6. Only subjects who get support for participation in the trial from their mental health clinician will be eligible to be enrolled in the study Some Common Exclusion Criteria: 1. Medications that might significantly interfere with the effects of the study medications 2. Cognitive dysfunction that could interfere with study participation 3. Alcohol or substance use disorder 4. Any lifetime history of hallucinogen use disorder 5. Regular use or misuse of hallucinogens 6. History of intolerance to perceptual altering drugs 7. Significant blood pressure problems 8. Pregnancy or currently breast feeding (lactation) 9. Any unstable medical conditions 10. Significant cardiovascular disease 11. Significantly abnormal laboratory test results 12. History of serotonin syndrome Some Exclusion criteria for MDD subjects: 1. Current primary psychiatric disorder other than MDD 2. Medically significant condition rendering unsuitability for the study Some Exclusion criteria for healthy controls: 1. No current DSM-V psychiatric disorder, excluding nicotine and caffeine use disorder 2. No family history of serious mental illness (e.g., schizophrenia, bipolar disorder) Some Inclusion criteria for healthy controls: 1. No current DSM-5 psychiatric disorder, excluding nicotine and caffeine use disorder 2. No lifetime use of psychiatric medication \>3 months (proxy for psychiatric disorders)
China Diabetes Cognitive Dysfunction Early Diagnosis and Intervention Study (China-DECODE Study)
NCT06650969
Recruiting
Conditions Type 2 Diabetes, Subjective Cognitive De...
Phase Not Applicable
Enrollment 10000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Naturalistic observation

Primary Outcomes

  • Prevalence, incidence of cognitive dysfunction in type 2 diabetes
  • Risk factors for cognitive dysfunction in type 2 diabetes, such as diabetes duration, poor glycemic control, hypertension, obesity, dyslipidemia, and active inflammation, et al.
  • Biomarkers of cognitive dysfunction in type 2 diabetes
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2016-10-01
Completion: 2034-10-01
Eligibility
Age: 45 Years
Sex: ALL
Volunteers: true
Enrollment: 10000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Principal Investigators:
  • Yan Bi, M.D., Ph.D. (STUDY_DIRECTOR) - Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Contact Information
Study Contact:
Yan Bi, M.D., Ph.D.
(86) 25-83105313
biyan@nju.edu.cn
Zhou Zhang, M.D., Ph.D.
(86) 25-83106666
zhangzhou@smail.nju.edu.cn
Interventions
  • Naturalistic observation
Study Locations (1 sites)
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu 210008 China
Eligibility Criteria
Inclusion Criteria: * Age ≥45 years; * Type 2 diabetes diagnosed according to the American Diabetes Association criteria; * Willingness and ability to complete systematic neuropsychological tests; * Understanding of the research procedures and methods, potential benefits and risks of the trial, and sign written informed consent. Exclusion Criteria: * Fewer than 6 years of education; * Left-handedness; * Dementia; * Acute metabolic complications such as diabetic ketoacidosis, hyperglycaemic hyperosmolar state and hypoglycaemic coma within the previous 3 months; * History or presence of neurological or psychiatric disorders; * Presence of hypothyroidism; * History of malignancy, or severe kidney or liver dysfunction.
A Randomized, Double-blind, Multi-center, Active-controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of THP-00101, THP-00102, and THP-00103 in Subjects With T2DM and Essential Hypertension
NCT06647745
Recruiting
Conditions Type 2 Diabetes, Hypertension
Phase PHASE3
Enrollment 221
Locations 2 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • THP-00101
  • THP-00102
  • THP-00103
  • THP-00104
  • THP-00105

Primary Outcomes

  • Changes in Hemoglobin A1c (HbA1c)
  • Changes in Mean Sitting Systolic Blood Pressure (MSSBP)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2025-04-10
Completion: 2026-12-01
Eligibility
Age: 19 Years
Sex: ALL
Volunteers: false
Enrollment: 221 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: THPharm Corp.
Contact Information
Study Contact:
Taehee Han, Dr.
827086572278
admin@thpharm.co.kr
Jaewoo Park
827086572278
jw.park@thpharm.co.kr
Interventions
  • THP-00101
  • THP-00102
  • THP-00103
  • THP-00104
  • THP-00105
Study Locations (2 sites)
The Catholic University of Korea, Yeouido ST. Mary's Hospital, Seoul, 07345 South Korea
Thammasat University Hospital, Pathum Thani, Changwat Pathum Thani 12120 Thailand
Eligibility Criteria
Inclusion Criteria: * Screening (V1) 1. Adult males and females aged 19 (the legal adult age of each country) and above on the date of written informed consent 2. Subjects with type 2 diabetes mellitus accompanied by essential hypertension 3. Subjects with the following hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) levels at screening (V1)\* * hemoglobin A1c less than or equal to 9.5% and more than 6.5% * fasting plasma glucose less than or equal to 270 mg/dL * Including subjects who did not use oral hypoglycemic agents within 8 weeks from screening and subjects who took metformin monotherapy or dual combination therapy that included metformin for 8 weeks or longer from screening 4. Subjects with the following mean sitting systolic blood pressure (MSSBP) measured in the reference arm\*\* at screening (V1)\*\*\* * If not taking antihypertensive agents: MSSBP less than 160 mmHg and more than 140 mmHg * If taking antihypertensive agents: MSSBP less than 160 mmHg and more than 130 mmHg \*\*Reference arm: The arm with the higher MSSBP after measuring it 3 times in each arm at screening (V1) (If the MSSBP is the same between both arms, then the arm with the higher mean sitting diastolic blood pressure (MSDBP) is selected as the reference arm.) \*\*\*Classified based on whether antihypertensive agents were administered within 4 weeks from screening (V1) 5 Subjects considered by the investigator appropriate to discontinue the use of oral hypoglycemic agents and antihypertensive agents, other than the existing metformin, during the study (with metformin maintained at a minimum of 1,000 mg/day) 6 Subjects who received a sufficient explanation of the objectives and content of the study and voluntarily provided written informed consent * Baseline (V2) 1\. Subjects with the following HbA1c and FPG levels at baseline (V2) - HbA1c less than or equal to 9.5% and more than 6.5% - FPG less than or equal to 270 mg/dL 2. Subjects with the following MSSBP measured in the reference arm at baseline (V2) - MSSBP less than 160 mmHg and more than 140 mmHg 3. Subjects who did not take oral hypoglycemic agents other than the same dose of metformin (More than 1,000 mg/day) for at least 8 weeks before baseline (V2) 4. Subjects who did not take antihypertensive agents for at least 2 weeks before baseline (V2) 5. Subjects with no disqualifying inclusion/exclusion criteria of screening (V1) when evaluating eligibility again at baseline (V2) 6. Subjects with compliance of 70% or higher with the investigational product during the run-in period * Extension Period 1. Subjects who have completed all procedures of the treatment period. Subjects who are unsuitable to participate in the study of the extension period, considering safety, etc., can be excluded. 2. Subjects who received a sufficient explanation of the objectives and content of the extension period study and voluntarily provided written informed consent Exclusion Criteria: 1\. Subjects with the following blood pressures measured at screening (V1) and randomization (V2) (1) Subjects with the following MSDBP measured in the reference arm * MSDBP ≥110 mmHg (2) Subjects with the following difference in mean blood pressure measured three times consecutively in each arm at least 2 minutes apart at screening (V1): MSSBP ≥20 mmHg and MSDBP ≥10 mmHg 2. Subjects with a BMI of \>35 kg/m2 3. Subjects with the following comorbidities or conditions 1. Mild to severe hepatic impairment 2. Biliary obstruction or cholestasis 3. AST or ALT ≥2 x ULN 4. Total bilirubin \>2 x ULN 5. Patients with moderate (stage 3b) or severe renal impairment (eGFR by IDMS-MDRD \<45 mL/min/1.73 m2) 6. Acute conditions that may affect renal function, such as dehydration, severe infection, cardiovascular collapse (shock), and sepsis 7. Diabetic precoma and coma 8. Severe infection or severe traumatism 9. Malnutrition, starvation, debilitation, pituitary insufficiency, or adrenal dysfunction 10. Acute or chronic diseases that may cause tissue hypoxia such as respiratory failure (pulmonary infarction and severe pulmonary dysfunction) and shock, and gastrointestinal disorders including dehydration, diarrhea, and vomiting 11. Orthostatic hypotension with symptoms 12. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmia considered clinically significant as judged by the investigator 13. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve stenosis 14. Wasting diseases, autoimmune diseases, and connective tissue diseases 15. Dysuria, anuria, oliguria, and ischuria that cannot be controlled by drugs 16. Gastrointestinal diseases that may affect the absorption of the investigational product (gastrointestinal ulcer, gastritis, gastric spasm, gastroesophageal reflux disease, Crohn's disease, etc.) 17. Subjects who are HBsAg positive§ or HCV antibody positive∥ §Subjects who are taking antiviral products stably may participate ∥Subjects with negative HCV RNA test results may participate 18. Subjects who are positive for HIV Ag/Ab combo test 4. Subjects with the following past medical history <!-- --> 1. Hereditary angioedema or angioedema caused by ACE inhibitor or angiotensin II antagonist treatment. 2. Hereditary problems such as galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption, etc. 3. Type 1 diabetes mellitus, secondary diabetes mellitus, lactic acidosis, acute or chronic metabolic acidosis, and ketoacidosis including diabetic ketoacidosis accompanied or not accompanied by coma 4. Drug abuse or alcohol abuse 5. Past medical history of secondary hypertension or all medical history suspected of secondary hypertension (not limited to the following: coarctation of aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, etc.) 6. Severe cardiac failure (NYHA class III and IV), ischemic heart disease (unstable angina and myocardial infarction), and peripheral vascular diseases that occurred within 24 weeks before screening (V1) 7. Severe cerebrovascular diseases (stroke, cerebral infarction, cerebral hemorrhage, etc.) that occurred within 24 weeks before screening (V1) 8. Moderate or malignant retinopathy that occurred within 24 weeks before screening (V1) (retinal hemorrhage, visual disturbance, and retinal microaneurysm that occurred within the last 24 weeks) 9. Urinary tract infection or genital infection that occurred within 16 weeks before screening (V1) 10. Malignant tumors that occurred within the last 5 years. Subjects who experienced no recurrence for at least 5 years after being declared cured or in the cases of basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, or carcinoma in situ at other sites, subjects who experienced no recurrence for at least 3 years after being declared cured can be enrolled based on the investigator's medical judgment 5. Subjects who received the following medication or non-pharmacological therapy at screening (V1) <!-- --> 1. Bariatric surgery or lap-band surgery within 12 months before screening (V1) 2. Percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery within 24 weeks before screening (V1) 3. Antiobestic drugs or drugs based on the investigator's judgment to be capable of having significant effects on weight control within 12 weeks before screening (V1) 4. Systemic corticosteroids used for 2 weeks or longer, within 8 weeks before screening (V1) (inhaled and topical agents, eye drops, intranasal, intra-articular administration, and other localized administrations are allowed regardless of duration) 5. Insulin injections or GLP-1 receptor agonists administered for more than 7 days consecutively or non-c