NCT01030458

Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial

Newer vs Older Antihypertensive Agents in African Hypertensive Patients Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: 30 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the blood pressure lowering efficacy of a treatment regimen based on a dihydropyridine calcium-channel blocker combined with an angiotensin II type-1 receptor blocker with the recommended treatment regimen based on a low-dose thiazide diuretic combined with a beta-blocker.

Detailed description

Primary objective: Sitting systolic blood pressure (average of three readings) will be the primary outcome variable. Secondary 1. To compare the time interval between the two treatment groups, which after randomisation will be required, to reach and maintain the target defined as a blood pressure below 140 mm Hg systolic and 90 mm Hg diastolic; 2. To compare the duration of follow-up, during which a steady blood pressure control will be achieved; 3. To evaluate the incidence of adverse events, symptoms, biochemical abnormalities and ECG changes in the two treatment groups; 4. To assess the adherence to antihypertensive treatment as well as the rate of drop-outs in both treatment arms during a six-month period.

Conditions

• Blood Pressure

Interventions

Type	Name	Description
DRUG	amlodipine 5/10 mg per day plus valsartan 160 mg/day	Amlodipine 5/10 mg/day plus valsartan 160 mg/day, once daily, in the morning
DRUG	hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day	hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day, once daily, in the morning

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2009-12-11
• Last updated: 2013-12-09
• Results posted: 2013-11-15

Locations

7 sites across 5 countries: Cameroon, Côte d’Ivoire, Gabon, Nigeria, Senegal