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

Blood Pressure Clinical Trial

— NOAAH  

Official title:

Newer vs Older Antihypertensive Agents in African Hypertensive Patients Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030458
• Other study ID #: NOAAH version 5.0.2
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2009
• Last updated: November 14, 2013
• Start date: September 2010
• Est. completion date: March 2012

Study information

• Verified date: November 2013
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cameroon: Ministry of Public HealthCote d'Ivoire: Ministry of Health and Public HygieneGabon: Ministry of HealthSenegal: Ministere de la santeNigeria: The National Agency for Food and Drug Administration and ControlIvory Coast: Ministry for the Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 69 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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
• 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

Locations

Country	Name	City	State
Cameroon	Ecole de Médecine de Douala	Douala
Cameroon	Hôpital Général de Yaoundé	Yaoundé
Côte D'Ivoire	Institut de Cardiologie d'Abidjan	Abidjan
Gabon	Hôpital Central Universitaire de Libreville	Libreville
Nigeria	University of Enugu	Enugu
Nigeria	University of Ilorin	Ilorin
Senegal	Hôpital Aristide Le Dantec	Dakar

Sponsors (9)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	Hospital Aristide Le Dantec, Dakar, Senegal, Institute of Cardiology Abidjan, University of Ilorin Teaching Hospital, University of Kinshasa, University of Libreville, University of Nigeria, Enugu Campus, University of Yaounde, Yaounde Central Hospital

Countries where clinical trial is conducted

Cameroon,  Côte D'Ivoire,  Gabon,  Nigeria,  Senegal, 

References & Publications (2)

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 Antihypertensiv — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to Blood Pressure Control	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	No
Secondary	Side-effects to Study Medications		6 months follow-up after randomization	No
Secondary	Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up	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	No

External Links

•   University of Kinshasa