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

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ClinicalTrials.gov Identifier: NCT01030458
Recruitment Status : Completed
First Posted : December 11, 2009
Results First Posted : November 15, 2013
Last Update Posted : December 9, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Blood Pressure Drug: amlodipine 5/10 mg per day plus valsartan 160 mg/day Drug: hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day Phase 4

Detailed Description:

Primary objective:

Sitting systolic blood pressure (average of three readings) will be the primary outcome variable.


  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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Newer vs Older Antihypertensive Agents in African Hypertensive Patients Trial
Study Start Date : September 2010
Primary Completion Date : March 2012
Study Completion Date : March 2012

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
Drug: 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
Other Name: ExForge®
Active Comparator: 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
Drug: 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 Name: Lodoz®

Outcome Measures

Primary Outcome Measures :
  1. Sitting Systolic Blood Pressure on Automated Measurement [ Time Frame: 6 months follow-up after randomization ]
    Blood pressure is measured by means of validated oscillometric OMRON 705IT recorders (OMRON Healthcare Europe BV, Nieuwegein, Netherlands), after the patient has been seated for 5 minutes in a quiet room, according to the ESC/ESH guidelines. Three consecutive blood pressure readings are obtained and the average of these 3 measurements is used as the primary outcome.

Secondary Outcome Measures :
  1. Time to Blood Pressure Control [ Time Frame: 6 months follow-up after randomization ]
    The time (in weeks) after randomisation that will be required to reach and maintain the target, defined as a blood pressure below 140 mmHg systolic and 90 mmHg diastolic.

  2. Side-effects to Study Medications [ Time Frame: 6 months follow-up after randomization ]
  3. Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up [ Time Frame: 6 months follow-up after randomization ]
    This variable gives the proportion of patients reaching blood pressure control over time (< 140 mmHg systolic and < 90 mmHg diastolic)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01030458

Ecole de Médecine de Douala
Douala, Cameroon
Hôpital Général de Yaoundé
Yaoundé, Cameroon, BP 5408
Côte D'Ivoire
Institut de Cardiologie d'Abidjan
Abidjan, Côte D'Ivoire, BP V 206
Hôpital Central Universitaire de Libreville
Libreville, Gabon, BP 4908
University of Enugu
Enugu, Nigeria
University of Ilorin
Ilorin, Nigeria, PMB 1515
Hôpital Aristide Le Dantec
Dakar, Senegal
Sponsors and Collaborators
Katholieke Universiteit Leuven
University of Kinshasa
Yaounde Central Hospital
University of Yaounde
University of Libreville
Institute of Cardiology Abidjan
University of Ilorin Teaching Hospital
University of Nigeria, Enugu Campus
Hospital Aristide Le Dantec, Dakar, Senegal
Principal Investigator: Samuel Kingue, MD Hôpital Général de Yaoundé, BP 5408, Yaoundé, Cameroun
Principal Investigator: Daniel Lemogoum, MD, PhD Université de Douala, Douala, Cameroon
Principal Investigator: Bruno Mipinda, MD Hôpital Central Universitaire de Libreville, Libreville, Gabon
Principal Investigator: Omotoso Babatunde, MD University of Ilorin, Ilorin, Nigeria
Principal Investigator: Ifeoma E Ulasi, MD University of Enugu, Enugu, Nigeria
Principal Investigator: Serigne Abdou Ba, MD Hôpital Aristide Le Dantec, Dakar, Sénégal
Study Chair: Jean-René M'Buyamba-Kabangu, MD, PhD University of Kinshasa, Kinshasa, Democratic Republic of Congo
Study Director: Jan A Staessen, MD, PhD University of Leuven, Leuven, Belgium
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jan A. Staessen, Professor of Medicine, MD, PhD, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01030458     History of Changes
Other Study ID Numbers: NOAAH version 5.0.2
First Posted: December 11, 2009    Key Record Dates
Results First Posted: November 15, 2013
Last Update Posted: December 9, 2013
Last Verified: November 2013

Keywords provided by Jan A. Staessen, Katholieke Universiteit Leuven:
Blood pressure
Blood pressure control

Additional relevant MeSH terms:
Antihypertensive Agents
Amlodipine, Valsartan Drug Combination
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents