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

Condition(s) targeted: Blood Pressure

Intervention: amlodipine 5/10 mg per day plus valsartan 160 mg/day (Drug); hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Kinshasa

Official(s) and/or principal investigator(s):
Samuel Kingue, MD, Principal Investigator, Affiliation: Hôpital Général de Yaoundé, BP 5408, Yaoundé, Cameroun
Daniel Lemogoum, MD, PhD, Principal Investigator, Affiliation: Université de Douala, Douala, Cameroon
Bruno Mipinda, MD, Principal Investigator, Affiliation: Hôpital Central Universitaire de Libreville, Libreville, Gabon
Evelyn Ake-Traboulsi, MD, Principal Investigator, Affiliation: Institut de Cardiologie d'Abidjan, Abidjan, Côte d'Ivoire
Omotoso Babatunde, MD, Principal Investigator, Affiliation: University of Ilorin, Ilorin, Nigeria
Ifeoma E Ulasi, MD, Principal Investigator, Affiliation: University of Enugu, Enugu, Nigeria
Serigne Abdou Ba, MD, Principal Investigator, Affiliation: Hôpital Aristide Le Dantec, Dakar, Sénégal
Jean-René M'Buyamba-Kabangu, MD, PhD, Study Chair, Affiliation: University of Kinshasa, Kinshasa, Democratic Republic of Congo
Jan A Staessen, MD, PhD, Study Director, Affiliation: University of Leuven, Leuven, Belgium

Overall contact:
Jean-René M'Buyamba-Kabangu, MD, PhD, Phone: 243-9999-44-232, Email: jerembu@yahoo.fr

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.

Official title: Newer vs Older Antihypertensive Agents in African Hypertensive Patients Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Sitting systolic blood pressure on automated measurement

Secondary outcome:

Time to blood pressure control

Side-effects to study medications

Time period during which blood pressure is controlled

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.

Minimum age: 30 Years. Maximum age: 69 Years. Gender(s): Both.

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.

Jean-René M'Buyamba-Kabangu, MD, PhD, Phone: 243-9999-44-232, Email: jerembu@yahoo.fr

Ecole de Médecine de Douala, Douala, Cameroon; Recruiting
Daniel Lemogoum, MD, Phone: 237993-5158, Email: dlems2002@yahoo.fr
Daniel Lemogoum, MD, Principal Investigator

Hôpital Général de Yaoundé, Yaoundé BP 5408, Cameroon; Recruiting
Samuel Kingue, MD, Phone: 237-77-70-04-77, Email: samuel_kingue@yahoo.fr
Samuel Kingue, MD, Principal Investigator

Institut de Cardiologie d'Abidjan, Abidjan BP V 206, Côte D'Ivoire; Not yet recruiting
Evelyn Ake-Traboulsi, MD, Phone: 225-07-67-65-01, Email: eveyaket@aviso.ci
Evelyn Ake-Traboulsi, MD, Principal Investigator

Hôpital Central Universitaire de Libreville, Libreville BP 4908, Gabon; Recruiting
Bruno Mipinda, MD, Phone: 241-06-05-59-65, Email: mipinda@yahoo.fr
Bruno Mipinda, MD, Principal Investigator

University of Enugu, Enugu, Nigeria; Recruiting
Ifeoma Ulasi, MD, Phone: 234-80-33-26-25-03, Email: ifeomaulasi@yahoo.co.uk
Ifeoma Ulasi, MD, Principal Investigator

University of Ilorin, Ilorin PMB 1515, Nigeria; Recruiting
Omotoso Babatunde, MD, Phone: 234-80-58-94-81-26, Email: abomotoso@hotmail.com
Omotoso Babatunde, MD, Principal Investigator

Hôpital Aristide Le Dantec, Dakar, Senegal; Recruiting
Serigne Abdou Ba, MD, Phone: 221-77-638-61-00, Email: saba@refer.sn
Serigne Abdou BA, MD, Principal Investigator
Mouhamadou Bamba Ndiaye, MD, Sub-Investigator

University of Kinshasa

Related publications:

Odili AN, Richart T, Thijs L, Kingue S, Boombhi HJ, Lemogoum D, Kaptue J, Kamden M, Mipinda JB, Omotoso BA, Kolo PM, Aderibigbe A, Ulasi II, Anisiuba BC, Ijoma CK, Ba SA, Ndiaye MB, Staessen JA, M'buyamba-Kabangu JR; On behalf of the NOAAH Investigators. Rationale and design of the Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) trial. Blood Press. 2011 Apr 15; [Epub ahead of print]

Starting date: September 2010
Last updated: May 17, 2011