Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial
NCT ID: NCT01030458
Last Updated: 2013-12-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
183 participants
INTERVENTIONAL
2010-09-30
2012-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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amlodipine plus valsartan
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.
amlodipine 5/10 mg per day plus valsartan 160 mg/day
Amlodipine 5/10 mg/day plus valsartan 160 mg/day, once daily, in the morning
hydrochlorothiazide plus bisoprolol
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
hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day
hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day, once daily, in the morning
Interventions
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amlodipine 5/10 mg per day plus valsartan 160 mg/day
Amlodipine 5/10 mg/day plus valsartan 160 mg/day, once daily, in the morning
hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day
hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day, once daily, in the morning
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
69 Years
ALL
No
Sponsors
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University of Kinshasa
OTHER
Yaounde Central Hospital
OTHER_GOV
University of Yaounde
OTHER
University of Libreville
UNKNOWN
Institute of Cardiology Abidjan
UNKNOWN
University of Ilorin Teaching Hospital
OTHER
University of Nigeria, Enugu Campus
OTHER
Hospital Aristide Le Dantec, Dakar, Senegal
UNKNOWN
KU Leuven
OTHER
Responsible Party
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Jan A. Staessen
Professor of Medicine, MD, PhD
Principal Investigators
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Samuel Kingue, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Général de Yaoundé, BP 5408, Yaoundé, Cameroun
Daniel Lemogoum, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Université de Douala, Douala, Cameroon
Bruno Mipinda, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Central Universitaire de Libreville, Libreville, Gabon
Omotoso Babatunde, MD
Role: PRINCIPAL_INVESTIGATOR
University of Ilorin, Ilorin, Nigeria
Ifeoma E Ulasi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Enugu, Enugu, Nigeria
Serigne Abdou Ba, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Aristide Le Dantec, Dakar, Sénégal
Jean-René M'Buyamba-Kabangu, MD, PhD
Role: STUDY_CHAIR
University of Kinshasa, Kinshasa, Democratic Republic of Congo
Jan A Staessen, MD, PhD
Role: STUDY_DIRECTOR
University of Leuven, Leuven, Belgium
Locations
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Ecole de Médecine de Douala
Douala, , Cameroon
Hôpital Général de Yaoundé
Yaoundé, , Cameroon
Institut de Cardiologie d'Abidjan
Abidjan, , Côte d’Ivoire
Hôpital Central Universitaire de Libreville
Libreville, , Gabon
University of Enugu
Enugu, , Nigeria
University of Ilorin
Ilorin, , Nigeria
Hôpital Aristide Le Dantec
Dakar, , Senegal
Countries
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References
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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.
M'Buyamba-Kabangu JR, Anisiuba BC, Ndiaye MB, Lemogoum D, Jacobs L, Ijoma CK, Thijs L, Boombhi HJ, Kaptue J, Kolo PM, Mipinda JB, Osakwe CE, Odili A, Ezeala-Adikaibe B, Kingue S, Omotoso BA, Ba SA, Ulasi II, Staessen JA; Newer versus Older Antihypertensive Agents in African Hypertensive Patients Trial (NOAAH) Investigators. Efficacy of newer versus older antihypertensive drugs in black patients living in sub-Saharan Africa. J Hum Hypertens. 2013 Dec;27(12):729-35. doi: 10.1038/jhh.2013.56. Epub 2013 Jun 27.
Osakwe CE, Jacobs L, Anisiuba BC, Ndiaye MB, Lemogoum D, Ijoma CK, Kamdem MM, Thijs L, Boombhi HJ, Kaptue J, Kolo PM, Mipinda JB, Odili AN, Ezeala-Adikaibe B, Kingue S, Omotoso BA, Ba SA, Ulasi II, M'buyamba-Kabangu JR, Staessen JA; Newer Versus Older Antihypertensive Agents in African Hypertensive Patients Trial (NOAAH) Investigators. Heart rate variability on antihypertensive drugs in black patients living in sub-Saharan Africa. Blood Press. 2014 Jun;23(3):174-80. doi: 10.3109/08037051.2013.836810. Epub 2013 Sep 25.
Odili AN, Ezeala-Adikaibe B, Ndiaye MB, Anisiuba BC, Kamdem MM, Ijoma CK, Kaptue J, Boombhi HJ, Kolo PM, Shu EN, Thijs L, Staessen JA, Omotoso BA, Kingue S, Ba SA, Lemogoum D, M'Buyamba-Kabangu JR, Ulasi II. Progress report on the first sub-Saharan Africa trial of newer versus older antihypertensive drugs in native black patients. Trials. 2012 May 17;13:59. doi: 10.1186/1745-6215-13-59.
Other Identifiers
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NOAAH version 5.0.2
Identifier Type: -
Identifier Source: org_study_id