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

November 14, 2013 updated by: Jan A. Staessen, KU Leuven

Newer vs Older Antihypertensive Agents in African Hypertensive Patients Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cameroon
      • Douala, Cameroon
        • Ecole de Médecine de Douala
      • Yaoundé, Cameroon, BP 5408
        • Hôpital Général de Yaoundé
  • Côte D'Ivoire
      • Abidjan, Côte D'Ivoire, BP V 206
        • Institut de Cardiologie d'Abidjan
  • Gabon
      • Libreville, Gabon, BP 4908
        • Hôpital Central Universitaire de Libreville
  • Nigeria
      • Enugu, Nigeria
        • University of Enugu
      • Ilorin, Nigeria, PMB 1515
        • University of Ilorin
  • Senegal
      • Dakar, Senegal
        • Hôpital Aristide Le Dantec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Lodoz®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months follow-up after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months follow-up after randomization
Side-effects to Study Medications
Time Frame: 6 months follow-up after randomization
6 months follow-up after randomization
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)
6 months follow-up after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Collaborators

University of Yaounde
University of Kinshasa
Yaounde Central Hospital
University of Nigeria, Enugu Campus
University of Ilorin Teaching Hospital
University of Libreville
Institute of Cardiology Abidjan
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

December 9, 2009

First Submitted That Met QC Criteria

December 10, 2009

First Posted (Estimate)

December 11, 2009

Study Record Updates

Last Update Posted (Estimate)

December 9, 2013

Last Update Submitted That Met QC Criteria

November 14, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOAAH version 5.0.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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