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

This study has been completed.
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Jan A. Staessen, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01030458
First received: December 9, 2009
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Newer vs Older Antihypertensive Agents in African Hypertensive Patients Trial

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Sitting Systolic Blood Pressure on Automated Measurement [ Time Frame: 6 months follow-up after randomization ] [ Designated as safety issue: No ]
    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:
  • Time to Blood Pressure Control [ Time Frame: 6 months follow-up after randomization ] [ Designated as safety issue: No ]
    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.

  • Side-effects to Study Medications [ Time Frame: 6 months follow-up after randomization ] [ Designated as safety issue: No ]
  • Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up [ Time Frame: 6 months follow-up after randomization ] [ Designated as safety issue: No ]
    This variable gives the proportion of patients reaching blood pressure control over time (< 140 mmHg systolic and < 90 mmHg diastolic)


Enrollment: 183
Study Start Date: September 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

Detailed Description:

Primary objective:

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.
  Eligibility

Ages Eligible for Study:   30 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030458

Locations
Cameroon
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
Gabon
Hôpital Central Universitaire de Libreville
Libreville, Gabon, BP 4908
Nigeria
University of Enugu
Enugu, Nigeria
University of Ilorin
Ilorin, Nigeria, PMB 1515
Senegal
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
Investigators
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:
Additional 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
Study First Received: December 9, 2009
Results First Received: July 9, 2013
Last Updated: November 14, 2013
Health Authority: Cameroon: Ministry of Public Health
Cote d'Ivoire: Ministry of Health and Public Hygiene
Gabon: Ministry of Health
Senegal: Ministere de la sante
Nigeria: The National Agency for Food and Drug Administration and Control
Ivory Coast: Ministry for the Public Health

Keywords provided by Katholieke Universiteit Leuven:
Blood pressure
Hypertension
Blacks
Africa
Blood pressure control
Side-effects

Additional relevant MeSH terms:
Valsartan
Amlodipine
Hydrochlorothiazide
Antihypertensive Agents
Bisoprolol
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 22, 2014