Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial
Condition: Blood Pressure
Intervention: amlodipine 5/10 mg per day plus valsartan 160 mg/day; hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day
Intervention description: Amlodipine 5/10 mg/day plus valsartan 160 mg/day, once daily, in the morning; hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day, once daily, in the morning
Intervention MeSH terms: Amlodipine; Valsartan; Hydrochlorothiazide; Bisoprolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 183.0
Sex: All
Minimum age: 30 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Blood pressure; Hypertension; Blacks; Africa; Blood pressure control; Side-effects

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women or men within an age range from 30 to 69 years with uncomplicated hypertension.

          -  Blood pressure measured in the sitting position after at least 5 minutes rest (average
             of three readings at the last run-in-visit) should range from 140 to 179 mm Hg
             systolic or from 90 to 109 mm Hg diastolic (grades 1 or 2 of hypertension). Patients
             must have uncomplicated hypertension with a maximum of two additional risk factors, as
             defined in the 2007 guidelines of the European Societies of Hypertension and
             Cardiology.

          -  Systolic blood pressure in the upright position must be at least 110 mm Hg (mean of
             three readings obtained immediately after the patient has assumed a standing
             position).

          -  Patients who have never been treated for hypertension or in whom previous
             antihypertensive drug treatment has been discontinued for at least four weeks before
             the last run-in visit can be randomised. If two weeks after discontinuation of
             previous antihypertensive treatment the blood pressure is higher than 160 mm Hg
             systolic or higher than 100 mm Hg diastolic and if the patient has complaints, the
             patient can be randomised immediately to active blood pressure lowering treatment with
             either the newer or older antihypertensive drugs.

          -  The patient must provide informed written consent.

        Exclusion Criteria:

          -  Premenopausal women not applying anticonception.

          -  A history of cardiovascular disease.

          -  Secondary hypertension.

          -  Electrocardiographic left ventricular hypertrophy.

          -  More than two cardiovascular risk factors in addition to hypertension.

          -  Diabetes mellitus.

          -  Renal dysfunction.

          -  Recent treatment with two or more antihypertensive drugs or a contra-indication to
             discontinue blood pressure lowering agents for 4 weeks.

          -  Severe non-cardiovascular disease.

          -  Known contra indications for the first-line study medications.