Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial
Information source: Katholieke Universiteit Leuven
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Link to the current ClinicalTrials.gov record.
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
Sponsored by: Katholieke Universiteit Leuven
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
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
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
Time to Blood Pressure Control
Side-effects to Study Medications
Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up
Sitting systolic blood pressure (average of three readings) will be the primary outcome
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
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.
- 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
- 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
- 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.
- 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.
Locations and Contacts
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
University of Kinshasa
Odili AN, Richart T, Thijs L, Kingue S, Boombhi HJ, Lemogoum D, Kaptue J, Kamdem MK, Mipinda JB, Omotoso BA, Kolo PM, Aderibigbe A, Ulasi II, Anisiuba BC, Ijoma CK, Ba SA, Ndiaye MB, Staessen JA, M'buyamba-Kabangu JR; NOAAH Investigators. Rationale and design of the Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) trial. Blood Press. 2011 Oct;20(5):256-66. doi: 10.3109/08037051.2011.572614. Epub 2011 Apr 15.
Starting date: September 2010
Last updated: November 14, 2013