Recruiting

Clinical Response of EXTOR (Amlodipine/Valsartan) in Newly Diagnosed Hypertensive Patients.

ClinicalTrials.gov IDNCT06625346

PhaseNot Applicable

Enrollment420

SponsorThe Searle Company Limited Pakistan

Age18 Years – 70 Years

SexALL

I'm interested View official listing

Conditions studied

Hypertension

About this study

The American College of Cardiology/American Heart Association hypertension guidelines recommend treatment initiation with dual antihypertensive therapy in adults with stage 2 hypertension (corresponding to grade 1 and 2 in the ESH classification) and an average BP \>20/10 mm Hg above target. Amlodipine and valsartan are two of the most commonly prescribed medications for the treatment of hypertension (high blood pressure). In Pakistan multiple studies were conducted on Hypertension and use of Single Pill Combination in uncontrolled Hypertension. However, no study was conducted to assess the role of Single Pill Combination (SPC) like Amlodipine and Valsartan in newly diagnosed hypertension and to assess their quality of life by patients' satisfaction with their medication after managing the hypertension with the SPC.

Interventions

Drug: Fixed-Dose Combination of Amlodipine/Valsartan — Amlodipine and valsartan are two of the most commonly prescribed medications for the treatment of hypertension (high blood pressure). Amlodipine is a calcium channel blocker that works by relaxing the blood vessels, while valsartan is an angiotensin receptor blocker that works by blocking the effects of the hormone angiotensin II, which causes blood vessels to constrict. The combination of amlodipine and valsartan in a single pill has been shown to be more effective in lowering blood pressure than either medication alone. This is because the two medications have different mechanisms of action and work together to provide a more comprehensive approach to blood pressure control.

Primary outcomes

To assess the effectiveness of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients in 8 weeks. (8 week)
To assess the Health-Related Quality of Life of newly diagnosed hypertensive patients managed by Extor (8 week)
To assess the overall safety of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients. (8 week)

Eligibility information

Inclusion Criteria: * Patient with a clinical history of Hypertension (systolic blood pressure greater than or equal to 140 mmHg or a diastolic blood pressure greater than or equal to 90 mmHg) and never had antihypertensive treatment. * Patient aged ≥18 and ≤70 years inclusive of either sex. * Patient with ability to understand and sign written informed consent form. Exclusion Criteria: * • Patients with already on antihypertensive treatment or secondary hypertension * Pregnant women or nursing mothers * Patients with acute illnesses or psychiatric diagnosis * Known hypersensitivity to Extor product, the metabolites, or formulation excipients. * Treated with Extor to evaluate safety as per approved prescribing information for Extor in Pakistan.

Study locations

Kuwait Teaching Hospital, Peshawar, KPK Pakistan
National Medical Centre, Karachi, Pakistan

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: 2026-11-01.