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Original Article

Rationale and design of the Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) trial

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Pages 256-266 | Received 21 Dec 2010, Accepted 09 Mar 2011, Published online: 15 Apr 2011
 

Abstract

Background. Sub-Saharan Africa experiences an epidemic surge in hypertension. Studies in African Americans led to the recommendation to initiate antihypertensive treatment in Blacks with a diuretic or a low-dose fixed combination including a diuretic. We mounted the Newer versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) trial to compare in native African patients a fixed combination of newer drugs, not involving a diuretic, with a combination of older drugs including a diuretic. Methods. Patients aged 30–69 years with uncomplicated hypertension (140–179/90–109 mmHg) and two or fewer associated risk factors are eligible. After a 4-week run-in period off treatment, 180 patients will be randomized to once daily bisoprolol/hydrochlorothiazide 5/6.25 mg or amlodipine/valsartan 5/160 mg. To attain and maintain blood pressure below 140/90 mmHg during 6 months of follow-up, the doses of bisoprolol and amlodipine in the combination tablets will be increased to 10 mg/day with the possible addition of α-methyldopa or hydralazine. NOAAH is powered to demonstrate a 5-mmHg between-group difference in sitting systolic pressure with a two-sided p-value of 0.01 and 90% power. NOAAH is investigator-led and complies with the Helsinki declaration. Results. Six centers in four sub-Saharan countries started patient recruitment on September 1, 2010. On December 1, 195 patients were screened, 171 were enrolled, and 51 were randomized and followed up. The trial will be completed in the third quarter of 2011. Conclusions. NOAAH (NCT01030458) is the first randomized multicenter trial of antihypertensive medications in hypertensive patients born and living in sub-Saharan Africa.

Acknowledgment

The Belgian Hypertension Committee endorsed the NOAAH trial. Prof. M. O'Rourke (Saint Vincent's Clinic, University of New South Wales, Sidney, Australia) helped in raising support for the ancillary substudy on arterial stiffness. The authors gratefully acknowledge the expert clerical and secretarial support of Ms. Sandra Covens, Ms. Ya Zhu and Ms. Barbara Andries.

Registration number: NCT01030458

Role of the funding source

Novartis provided unrestricted financial support and the Exforge study medication. The funding source had no role in the design of the trial, data collection, database management, statistical analysis or writing of the report. The sponsor (J.R. M'Buyamba-Kabangu) and the scientific coordinator (J.A. Staessen) had full access to all of the data and accept the final responsibility for the decision to submit this manuscript for publication. Novartis was permitted to review the manuscript and suggest changes, but the authors retained the final decision on the content of this article.

Conflict of interest

None of the authors declares a conflict of interest with regard to the information presented in this manuscript.