NCT06625346

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

Clinical Outcomes in Newly Diagnosed Hypertensive Patients With EXTOR (Fixed-Dose Combination of Amlodipine/Valsartan) in Routine Pakistani Practice.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 420 (estimated)
• Sponsor: The Searle Company Limited Pakistan · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

To assess the effectiveness of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients in 8 weeks. * Change from Baseline to 8 weeks in Systolic Blood Pressure (SBP) From standard Blood Pressure Measurement. * Change from Baseline to 8 weeks in Diastolic Blood Pressure (DBP) From standard Blood Pressure Measurement. * Change from Baseline to 8 weeks in the Health-Related Quality of Life of newly diagnosed hypertensive patients managed by Extor: assess by Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) * Change from baseline to 4 weeks in Diastolic Blood Pressure (SBP) From standard Blood Pressure Measurement * Change from baseline to 4 weeks in Diastolic Blood Pressure (DBP) From standard Blood Pressure Measurement * Change from baseline to 4 weeks in the Health-Related Quality of Life of newly diagnosed hypertensive patients managed by Extor: assess by Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) * To assess the overall safety of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients. Note: The safety is assessed in all subjects who received at least one dose of study drug.

Conditions

• Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-28
• Primary completion: 2025-08-30
• Completion: 2025-09-15
• First posted: 2024-10-03
• Last updated: 2025-05-15

Locations

2 sites across 1 country: Pakistan