title: Rationale and design of the Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) trial.
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.
authors.affiliation: Studies Coordinating Centre, Division of Hypertension and Cardiovascular Rehabilitation, Department of Cardiovascular Diseases, University of Leuven, Leuven, Belgium.
authors.forename: Augustine N
authors.initials: AN
authors.lastname: Odili
authors.forename: Tom
authors.initials: T
authors.lastname: Richart
authors.forename: Lutgarde
authors.initials: L
authors.lastname: Thijs
authors.forename: Samuel
authors.initials: S
authors.lastname: Kingue
authors.forename: Hilaire J
authors.initials: HJ
authors.lastname: Boombhi
authors.forename: Daniel
authors.initials: D
authors.lastname: Lemogoum
authors.forename: Joseph
authors.initials: J
authors.lastname: Kaptue
authors.forename: Marius K
authors.initials: MK
authors.lastname: Kamdem
authors.forename: Jean-Bruno
authors.initials: JB
authors.lastname: Mipinda
authors.forename: Babatunde A
authors.initials: BA
authors.lastname: Omotoso
authors.forename: Philip M
authors.initials: PM
authors.lastname: Kolo
authors.forename: Ademola
authors.initials: A
authors.lastname: Aderibigbe
authors.forename: Ifeoma I
authors.initials: II
authors.lastname: Ulasi
authors.forename: Benedict C
authors.initials: BC
authors.lastname: Anisiuba
authors.forename: Chinwuba K
authors.initials: CK
authors.lastname: Ijoma
authors.forename: Serigne A
authors.initials: SA
authors.lastname: Ba
authors.forename: Mouhamadou B
authors.initials: MB
authors.lastname: Ndiaye
authors.forename: Jan A
authors.initials: JA
authors.lastname: Staessen
authors.forename: Jean-René
authors.initials: JR
authors.lastname: M'buyamba-Kabangu
mesh_terms: D000328:Adult; D017954:Africa South of the Sahara / Q000453:epidemiology; D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D017298:Bisoprolol / Q000008:administration & dosage / Q000627:therapeutic use; D044383:Black People; D001794:Blood Pressure / Q000187:drug effects*; D018660:Blood Pressure Monitoring, Ambulatory; D004232:Diuretics / Q000008:administration & dosage / Q000627:therapeutic use; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006830:Hydralazine / Q000008:administration & dosage / Q000627:therapeutic use; D006852:Hydrochlorothiazide / Q000008:administration & dosage / Q000627:therapeutic use; D006973:Hypertension / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D008297:Male; D008750:Methyldopa / Q000008:administration & dosage / Q000627:therapeutic use; D008875:Middle Aged; D012107:Research Design; D012307:Risk Factors; D013777:Tetrazoles / Q000008:administration & dosage / Q000627:therapeutic use; D014633:Valine / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use; D000068756:Valsartan; D001741:Black or African American
chemical_list: D000959:Antihypertensive Agents; D004232:Diuretics; D004338:Drug Combinations; D013777:Tetrazoles; C086062:bisoprolol, hydrochlorothiazide drug combination; D006852:Hydrochlorothiazide; D017311:Amlodipine; D006830:Hydralazine; D008750:Methyldopa; D000068756:Valsartan; D014633:Valine; D017298:Bisoprolol