Recruiting
Clinical Trial to Evaluate the Efficacy and Safety of Monotherapy Group of HL1113R1 or HL1113R2 Versus HL1113 (Fixed Dose Combination) in Patients With Essential Hypertension and Type II Diabetes Mellitus
This clinical trial is a randomized, active controlled, double blind, parallel, multi center, phase 3 study to evaluate the efficacy and safety of monotherapy group of HL1113R1 or HL1113R2 versus HL1113 (Fixed dose combination) in patients with essential hypertension and type II diabetes mellitus
ClinicalTrials.gov IDNCT07552389
PhasePHASE3
Enrollment228
SponsorHanlim Pharm. Co., Ltd.
Age19 Years and older
SexALL
Conditions studied
Hypertension, Diabete Type 2
About this study
This clinical trial is a randomized, active controlled, double blind, parallel, multi center, phase 3 study to evaluate the efficacy and safety of monotherapy group of HL1113R1 or HL1113R2 versus HL1113 (Fixed dose combination) in patients with essential hypertension and type II diabetes mellitus
Interventions
- Drug: Test group — HL1113T2 + placebo of HL1113T1, HL1113R1, HL1113R2, once daily, administered for 12 weeks
- Drug: Exploratory test group — HL1113T1 + placebo of HL1113T2, HL1113R1, HL1113R2, once daily, administered for 12 weeks
- Drug: Control group 1 — HL1113R1 + placebo of HL1113T1, HL1113T2, HL1113R2, once daily, administered for 12 weeks
- Drug: Control group 2 — HL1113R2 + placebo of HL1113T1, HL1113T2, HL1113R1, once daily, administered for 12 weeks
Primary outcomes
- Change from baseline in mean seated systolic blood pressure (MSSBP) at Week 12, comparing HL1113T2 with HL1113R2 monotherapy (Test group vs Control group 2) (Baseline, 12weeks)
- Change from baseline in HbA1c at Week 12, comparing HL1113T2 with HL1113R1 monotherapy (Test group vs Control group 1) (Baseline, 12weeks)
Eligibility information
Inclusion Criteria:
* Adult male or female subjects aged ≥19 years at the time of written informed consent.
* Subjects diagnosed with essential hypertension accompanied by type 2 diabetes mellitus.
* etc.
Exclusion Criteria:
* Subjects whose blood pressure measured in the selected arm at both screening and randomization meets the following criterion: MSDBP ≥ 110 mmHg
* Subjects whose blood pressure measured three consecutive times in each arm at intervals of at least 2 minutes at screening shows a difference of ≥20 mmHg in SBP and ≥10 mmHg in DBP.
* etc.
Study locations
- The Catholic University of Korea Bucheon St. Mary's Hospital, Seoul, South Korea
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-06.