Overview

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

Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Katholieke Universiteit Leuven
KU Leuven
Collaborators:
Hospital Aristide Le Dantec, Dakar, Senegal
Institute of Cardiology Abidjan
University of Ilorin Teaching Hospital
University of Kinshasa
University of Libreville
University of Nigeria, Enugu Campus
University of Yaounde
Yaounde Central Hospital
Treatments:
Amlodipine
Amlodipine, Valsartan Drug Combination
Antihypertensive Agents
Bisoprolol
Hydrochlorothiazide
Valsartan
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.