Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Kinshasa.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Kinshasa
Collaborators:
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:
University of Kinshasa
ClinicalTrials.gov Identifier:
NCT01030458
First received: December 9, 2009
Last updated: May 17, 2011
Last verified: April 2011
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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:
Drug Information available for:
Hydrochlorothiazide
Bisoprolol
Bisoprolol hydrochloride
Amlodipine
Bisoprolol fumarate
Amlodipine besylate
Valsartan
U.S. FDA Resources
Further study details as provided by University of Kinshasa:
Primary Outcome Measures:
- Sitting systolic blood pressure on automated measurement [ Time Frame: 6 months follow-up after randomization ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to blood pressure control [ Time Frame: 6 months follow-up after randomization ] [ Designated as safety issue: No ]
- Side-effects to study medications [ Time Frame: 6 months follow-up after randomization ] [ Designated as safety issue: No ]
- Time period during which blood pressure is controlled [ Time Frame: 6 months follow-up after randomization ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | November 2011 (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
- 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;
- To compare the duration of follow-up, during which a steady blood pressure control will be achieved;
- To evaluate the incidence of adverse events, symptoms, biochemical abnormalities and ECG changes in the two treatment groups;
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030458
Contacts
| Contact: Jean-René M'Buyamba-Kabangu, MD, PhD | 243-9999-44-232 | jerembu@yahoo.fr |
| Contact: Jan A Staessen, MD, PhD | 32-16-34-7104 | jan.staessen@med.kuleuven.be |
Locations
| Cameroon | |
| Ecole de Médecine de Douala | Recruiting |
| Douala, Cameroon | |
| Contact: Daniel Lemogoum, MD 237993-5158 dlems2002@yahoo.fr | |
| Principal Investigator: Daniel Lemogoum, MD | |
| Hôpital Général de Yaoundé | Recruiting |
| Yaoundé, Cameroon, BP 5408 | |
| Contact: Samuel Kingue, MD 237-77-70-04-77 samuel_kingue@yahoo.fr | |
| Principal Investigator: Samuel Kingue, MD | |
| Côte D'Ivoire | |
| Institut de Cardiologie d'Abidjan | Not yet recruiting |
| Abidjan, Côte D'Ivoire, BP V 206 | |
| Contact: Evelyn Ake-Traboulsi, MD 225-07-67-65-01 eveyaket@aviso.ci | |
| Principal Investigator: Evelyn Ake-Traboulsi, MD | |
| Gabon | |
| Hôpital Central Universitaire de Libreville | Recruiting |
| Libreville, Gabon, BP 4908 | |
| Contact: Bruno Mipinda, MD 241-06-05-59-65 mipinda@yahoo.fr | |
| Principal Investigator: Bruno Mipinda, MD | |
| Nigeria | |
| University of Enugu | Recruiting |
| Enugu, Nigeria | |
| Contact: Ifeoma Ulasi, MD 234-80-33-26-25-03 ifeomaulasi@yahoo.co.uk | |
| Principal Investigator: Ifeoma Ulasi, MD | |
| University of Ilorin | Recruiting |
| Ilorin, Nigeria, PMB 1515 | |
| Contact: Omotoso Babatunde, MD 234-80-58-94-81-26 abomotoso@hotmail.com | |
| Principal Investigator: Omotoso Babatunde, MD | |
| Senegal | |
| Hôpital Aristide Le Dantec | Recruiting |
| Dakar, Senegal | |
| Contact: Serigne Abdou Ba, MD 221-77-638-61-00 saba@refer.sn | |
| Principal Investigator: Serigne Abdou BA, MD | |
| Sub-Investigator: Mouhamadou Bamba Ndiaye, MD | |
Sponsors and 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
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: | Evelyn Ake-Traboulsi, MD | Institut de Cardiologie d'Abidjan, Abidjan, Côte d'Ivoire |
| 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: | Professor Jean-René M'Buyamba-Kabangu, University of Kinshasa |
| ClinicalTrials.gov Identifier: | NCT01030458 History of Changes |
| Other Study ID Numbers: | NOAAH version 5.0.2 |
| Study First Received: | December 9, 2009 |
| Last Updated: | May 17, 2011 |
| 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 University of Kinshasa:
|
Blood pressure Hypertension Blacks |
Africa Blood pressure control Side-effects |
Additional relevant MeSH terms:
|
Valsartan Amlodipine, valsartan drug combination Antihypertensive Agents Hydrochlorothiazide Amlodipine Bisoprolol Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Vasodilator Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013