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

Newer vs Older Antihypertensive Agents in African Hypertensive Patients Trial

Sponsors

Lead Sponsor: KU Leuven

Collaborator: University of Kinshasa
Yaounde Central Hospital
University of Yaounde
University of Libreville
Institute of Cardiology Abidjan
University of Ilorin Teaching Hospital
University of Nigeria, Enugu Campus
Hospital Aristide Le Dantec, Dakar, Senegal

Source KU Leuven
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.

Overall Status Completed
Start Date September 2010
Completion Date March 2012
Primary Completion Date March 2012
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Sitting Systolic Blood Pressure on Automated Measurement 6 months follow-up after randomization
Secondary Outcome
Measure Time Frame
Time to Blood Pressure Control 6 months follow-up after randomization
Side-effects to Study Medications 6 months follow-up after randomization
Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up 6 months follow-up after randomization
Enrollment 183
Condition
Intervention

Intervention Type: Drug

Intervention Name: amlodipine 5/10 mg per day plus valsartan 160 mg/day

Description: Amlodipine 5/10 mg/day plus valsartan 160 mg/day, once daily, in the morning

Arm Group Label: amlodipine plus valsartan

Other Name: ExForge®

Intervention Type: Drug

Intervention Name: hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day

Description: hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day, once daily, in the morning

Arm Group Label: hydrochlorothiazide plus bisoprolol

Other Name: Lodoz®

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.

Gender: All

Minimum Age: 30 Years

Maximum Age: 69 Years

Healthy Volunteers: No

Overall Official
Location
Facility:
Ecole de Médecine de Douala | Douala, Cameroon
Hôpital Général de Yaoundé | Yaoundé, BP 5408, Cameroon
Institut de Cardiologie d'Abidjan | Abidjan, BP V 206, Côte D'Ivoire
Hôpital Central Universitaire de Libreville | Libreville, BP 4908, Gabon
University of Enugu | Enugu, Nigeria
University of Ilorin | Ilorin, PMB 1515, Nigeria
Hôpital Aristide Le Dantec | Dakar, Senegal
Location Countries

Cameroon

Côte D'Ivoire

Gabon

Nigeria

Senegal

Verification Date

November 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: KU Leuven

Investigator Full Name: Jan A. Staessen

Investigator Title: Professor of Medicine, MD, PhD

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: amlodipine plus valsartan

Type: Experimental

Description: 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.

Label: hydrochlorothiazide plus bisoprolol

Type: Active Comparator

Description: 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

Acronym NOAAH
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov