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| Name | Class |
|---|---|
| University of Kinshasa | OTHER |
| Yaounde Central Hospital | OTHER_GOV |
| University of Yaounde | OTHER |
| University of Libreville |
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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.
Primary objective:
Sitting systolic blood pressure (average of three readings) will be the primary outcome variable.
Secondary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Side-effects to Study Medications |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ecole de Médecine de Douala | Douala | Cameroon | ||||
| Hôpital Général de Yaoundé |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21495829 | Background | 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. | |
| 23803591 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Amlodipine Plus Valsartan | In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and to achieve blood pressure control, the study medication could be up-titrated to amlodipine 10 mg plus 160 mg valsartan. Patients take the study medication once a day, in the morning. Follow-up visits will take place at 2 weeks, 1 month and every month thereafter, up until 6 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| UNKNOWN |
| Institute of Cardiology Abidjan | UNKNOWN |
| University of Ilorin Teaching Hospital | OTHER |
| University of Nigeria, Enugu Campus | OTHER |
| Hospital Aristide Le Dantec, Dakar, Senegal | UNKNOWN |
Not provided
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| 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 |
|
|
| 6 months follow-up after randomization |
| 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 |
| Yaoundé |
| BP 5408 |
| Cameroon |
| Institut de Cardiologie d'Abidjan | Abidjan | BP V 206 | Côte d’Ivoire |
| Hôpital Central Universitaire de Libreville | Libreville | BP 4908 | Gabon |
| University of Enugu | Enugu | Nigeria |
| University of Ilorin | Ilorin | PMB 1515 | Nigeria |
| Hôpital Aristide Le Dantec | Dakar | Senegal |
| Result |
| 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. |
| 24066715 | Derived | 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. |
| 22594907 | 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. |
| FG001 | Hydrochlorothiazide Plus Bisoprolol | In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg and to achieve blood pressure control, the study medication could be up-titrated to 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol. Patients take the study medication once a day, in the morning. Follow-up visits will take place at 2 weeks, 1 month and every month thereafter, up until 6 months. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The main analysis included all randomised patients with at least one follow-up visit, according to the intention-to-treat principle. | Posted | Mean | Standard Deviation | mmHg | 6 months follow-up after randomization |
|
|
| ||||||||||||||||||||||||||||
| 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. | Posted | Median | Inter-Quartile Range | weeks | 6 months follow-up after randomization |
|
| ||||||||||||||||||||||||||||||
| Secondary | Side-effects to Study Medications | Posted | Number | participants | 6 months follow-up after randomization |
|
| ||||||||||||||||||||||||||||||||
| 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) | Posted | Number | participants | 6 months follow-up after randomization |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 94 | 1 | 94 | ||
| EG001 | 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 | 0 | 89 | 1 | 89 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia/asthenia | Nervous system disorders |
| |||
| Bilateral leg oedema | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Jan A Staessen | University of Leuven | +32 16 34 7104 | jan.staessen@med.kuleuven.be |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D000068756 | Valsartan |
| D000068838 | Amlodipine, Valsartan Drug Combination |
| D006852 | Hydrochlorothiazide |
| D017298 | Bisoprolol |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
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| >=65 years |
|
| Male |
|
| Senegal |
|
| Gabon |
|
| Cameroon |
|
|
|
|