Conditions: Blood Pressure
Keywords: Blood pressure Hypertension Blacks Africa Blood pressure control Side-effects
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 183
Healthy volunteers: no

Brief 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.

Arms:
arm 1: In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan. arm 2: In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol

Interventions: intervention 1: amlodipine 5/10 mg per day plus valsartan 160 mg/day intervention 2: hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day
Intervention descriptions: intervention 1: Amlodipine 5/10 mg/day plus valsartan 160 mg/day, once daily, in the morning intervention 2: hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day, once daily, in the morning

Protocol document: