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

NCT01030458 | Completed Phase 4 Results DMC

• 1 other identifier: NOAAH version 5.0.2
• Study Type: interventional
• Target: 183
• Locations: 5 countries
• Sites: 7

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.

Conditions

Blood Pressure

Keywords

Blood pressure; Hypertension; Blacks; Africa; Blood pressure control; Side-effects

Outcome Measures

Primary Outcomes (1)

• Sitting Systolic Blood Pressure on Automated Measurement

  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 Outcomes (3)

• Time to Blood Pressure Control

  6 months follow-up after randomization

• Side-effects to Study Medications

  6 months follow-up after randomization

• Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up

  6 months follow-up after randomization

Study Arms (2)

amlodipine plus valsartan

EXPERIMENTAL

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

hydrochlorothiazide plus bisoprolol

ACTIVE COMPARATOR

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

Interventions

amlodipine 5/10 mg per day plus valsartan 160 mg/day DRUG

Amlodipine 5/10 mg/day plus valsartan 160 mg/day, once daily, in the morning

Also known as: ExForge®

amlodipine plus valsartan

hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day DRUG

hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day, once daily, in the morning

Also known as: Lodoz®

hydrochlorothiazide plus bisoprolol

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead
• University of Kinshasa: collaborator
• Yaounde Central Hospital: collaborator
• University of Yaounde: collaborator
• University of Libreville: collaborator
• Institute of Cardiology Abidjan: collaborator
• University of Ilorin Teaching Hospital: collaborator
• University of Nigeria, Enugu Campus: collaborator
• Hospital Aristide Le Dantec, Dakar, Senegal: collaborator

Study Sites (7)

Ecole de Médecine de Douala

Douala, Cameroon

Location

Hôpital Général de Yaoundé

Yaoundé, BP 5408, Cameroon

Location

Institut de Cardiologie d'Abidjan

Abidjan, BP V 206, Côte d’Ivoire

Location

Hôpital Central Universitaire de Libreville

Libreville, BP 4908, Gabon

Location

University of Enugu

Enugu, Nigeria

Location

University of Ilorin

Ilorin, PMB 1515, Nigeria

Location

Hôpital Aristide Le Dantec

Dakar, Senegal

Location

Related Publications (4)

• 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.

  PMID: 21495829 BACKGROUND

• 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.

  PMID: 23803591 RESULT

• 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.

  PMID: 24066715 DERIVED

• 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.

  PMID: 22594907 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine; Valsartan; Amlodipine, Valsartan Drug Combination; Hydrochlorothiazide; Bisoprolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Azoles; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Drug Combinations; Pharmaceutical Preparations; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines

Results Point of Contact

• Title: Prof. Dr. Jan A Staessen
• Organization: University of Leuven

jan.staessen@med.kuleuven.be

+32 16 34 7104

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Jean-René M'Buyamba-Kabangu, MD, PhD

  University of Kinshasa, Kinshasa, Democratic Republic of Congo

  STUDY CHAIR

• Jan A Staessen, MD, PhD

  University of Leuven, Leuven, Belgium

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, MD, PhD

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 11, 2009
• Study Start: September 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 9, 2013
• Results First Posted: November 15, 2013

Record last verified: 2013-11

Locations

CA (2); CÔ (1); GA (1); NG (2); SE (1)