Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-26 @ 2:17 AM
Study NCT ID:
NCT01030458
Status:
COMPLETED
Last Update Posted:
2013-12-09
First Post:
2009-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D000068756', 'term': 'Valsartan'}, {'id': 'D000068838', 'term': 'Amlodipine, Valsartan Drug Combination'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}, {'id': 'D017298', 'term': 'Bisoprolol'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jan.staessen@med.kuleuven.be', 'phone': '+32 16 34 7104', 'title': 'Prof. Dr. Jan A Staessen', 'organization': 'University of Leuven'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Amlodipine Plus Valsartan', 'description': '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.', 'otherNumAtRisk': 94, 'otherNumAffected': 1, 'seriousNumAtRisk': 94, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Hydrochlorothiazide Plus Bisoprolol', 'description': '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', 'otherNumAtRisk': 89, 'otherNumAffected': 1, 'seriousNumAtRisk': 89, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Insomnia/asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Bilateral leg oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sitting Systolic Blood Pressure on Automated Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine Plus Valsartan', 'description': '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.'}, {'id': 'OG001', 'title': 'Hydrochlorothiazide Plus Bisoprolol', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '127.2', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '134.1', 'spread': '13.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months follow-up after randomization', 'description': '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.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The main analysis included all randomised patients with at least one follow-up visit, according to the intention-to-treat principle.'}, {'type': 'SECONDARY', 'title': 'Time to Blood Pressure Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine Plus Valsartan', 'description': '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.'}, {'id': 'OG001', 'title': 'Hydrochlorothiazide Plus Bisoprolol', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '20'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months follow-up after randomization', 'description': '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.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Side-effects to Study Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine Plus Valsartan', 'description': '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.'}, {'id': 'OG001', 'title': 'Hydrochlorothiazide Plus Bisoprolol', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months follow-up after randomization', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine Plus Valsartan', 'description': '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.'}, {'id': 'OG001', 'title': 'Hydrochlorothiazide Plus Bisoprolol', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '20'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '24'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months follow-up after randomization', 'description': 'This variable gives the proportion of patients reaching blood pressure control over time (\\< 140 mmHg systolic and \\< 90 mmHg diastolic)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amlodipine Plus Valsartan', 'description': '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.'}, {'id': 'FG001', 'title': 'Hydrochlorothiazide Plus Bisoprolol', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Logistical reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Moved or changed job', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Side effect of medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Amlodipine Plus Valsartan', 'description': '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.'}, {'id': 'BG001', 'title': 'Hydrochlorothiazide Plus Bisoprolol', 'description': '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'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '51.2', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '51.2', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Nigeria', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}, {'title': 'Senegal', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Gabon', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Cameroon', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-14', 'studyFirstSubmitDate': '2009-12-09', 'resultsFirstSubmitDate': '2013-07-09', 'studyFirstSubmitQcDate': '2009-12-10', 'lastUpdatePostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-13', 'studyFirstPostDateStruct': {'date': '2009-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sitting Systolic Blood Pressure on Automated Measurement', 'timeFrame': '6 months follow-up after randomization', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Time to Blood Pressure Control', 'timeFrame': '6 months follow-up after randomization', 'description': '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.'}, {'measure': 'Side-effects to Study Medications', 'timeFrame': '6 months follow-up after randomization'}, {'measure': 'Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up', 'timeFrame': '6 months follow-up after randomization', 'description': 'This variable gives the proportion of patients reaching blood pressure control over time (\\< 140 mmHg systolic and \\< 90 mmHg diastolic)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Blood pressure', 'Hypertension', 'Blacks', 'Africa', 'Blood pressure control', 'Side-effects'], 'conditions': ['Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '21495829', 'type': 'BACKGROUND', '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."}, {'pmid': '23803591', 'type': 'RESULT', 'citation': "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': '24066715', 'type': 'DERIVED', 'citation': "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': '22594907', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Primary objective:\n\nSitting systolic blood pressure (average of three readings) will be the primary outcome variable.\n\nSecondary\n\n1. 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;\n2. To compare the duration of follow-up, during which a steady blood pressure control will be achieved;\n3. To evaluate the incidence of adverse events, symptoms, biochemical abnormalities and ECG changes in the two treatment groups;\n4. To assess the adherence to antihypertensive treatment as well as the rate of drop-outs in both treatment arms during a six-month period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women or men within an age range from 30 to 69 years with uncomplicated hypertension.\n* 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.\n* 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).\n* 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.\n* The patient must provide informed written consent.\n\nExclusion Criteria:\n\n* Premenopausal women not applying anticonception.\n* A history of cardiovascular disease.\n* Secondary hypertension.\n* Electrocardiographic left ventricular hypertrophy.\n* More than two cardiovascular risk factors in addition to hypertension.\n* Diabetes mellitus.\n* Renal dysfunction.\n* Recent treatment with two or more antihypertensive drugs or a contra-indication to discontinue blood pressure lowering agents for 4 weeks.\n* Severe non-cardiovascular disease.\n* Known contra indications for the first-line study medications.'}, 'identificationModule': {'nctId': 'NCT01030458', 'acronym': 'NOAAH', 'briefTitle': 'Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Newer vs Older Antihypertensive Agents in African Hypertensive Patients Trial', 'orgStudyIdInfo': {'id': 'NOAAH version 5.0.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'amlodipine plus valsartan', 'description': '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.', 'interventionNames': ['Drug: amlodipine 5/10 mg per day plus valsartan 160 mg/day']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hydrochlorothiazide plus bisoprolol', 'description': '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', 'interventionNames': ['Drug: hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day']}], 'interventions': [{'name': 'amlodipine 5/10 mg per day plus valsartan 160 mg/day', 'type': 'DRUG', 'otherNames': ['ExForge®'], 'description': 'Amlodipine 5/10 mg/day plus valsartan 160 mg/day, once daily, in the morning', 'armGroupLabels': ['amlodipine plus valsartan']}, {'name': 'hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day', 'type': 'DRUG', 'otherNames': ['Lodoz®'], 'description': 'hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day, once daily, in the morning', 'armGroupLabels': ['hydrochlorothiazide plus bisoprolol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Douala', 'country': 'Cameroon', 'facility': 'Ecole de Médecine de Douala', 'geoPoint': {'lat': 4.04827, 'lon': 9.70428}}, {'zip': 'BP 5408', 'city': 'Yaoundé', 'country': 'Cameroon', 'facility': 'Hôpital Général de Yaoundé', 'geoPoint': {'lat': 3.86667, 'lon': 11.51667}}, {'zip': 'BP V 206', 'city': 'Abidjan', 'country': 'Côte d’Ivoire', 'facility': "Institut de Cardiologie d'Abidjan", 'geoPoint': {'lat': 5.35444, 'lon': -4.00167}}, {'zip': 'BP 4908', 'city': 'Libreville', 'country': 'Gabon', 'facility': 'Hôpital Central Universitaire de Libreville', 'geoPoint': {'lat': 0.39241, 'lon': 9.45356}}, {'city': 'Enugu', 'country': 'Nigeria', 'facility': 'University of Enugu', 'geoPoint': {'lat': 6.44132, 'lon': 7.49883}}, {'zip': 'PMB 1515', 'city': 'Ilorin', 'country': 'Nigeria', 'facility': 'University of Ilorin', 'geoPoint': {'lat': 8.49664, 'lon': 4.54214}}, {'city': 'Dakar', 'country': 'Senegal', 'facility': 'Hôpital Aristide Le Dantec', 'geoPoint': {'lat': 14.6937, 'lon': -17.44406}}], 'overallOfficials': [{'name': 'Samuel Kingue, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Général de Yaoundé, BP 5408, Yaoundé, Cameroun'}, {'name': 'Daniel Lemogoum, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Douala, Douala, Cameroon'}, {'name': 'Bruno Mipinda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Central Universitaire de Libreville, Libreville, Gabon'}, {'name': 'Omotoso Babatunde, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ilorin, Ilorin, Nigeria'}, {'name': 'Ifeoma E Ulasi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Enugu, Enugu, Nigeria'}, {'name': 'Serigne Abdou Ba, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Aristide Le Dantec, Dakar, Sénégal'}, {'name': "Jean-René M'Buyamba-Kabangu, MD, PhD", 'role': 'STUDY_CHAIR', 'affiliation': 'University of Kinshasa, Kinshasa, Democratic Republic of Congo'}, {'name': 'Jan A Staessen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Leuven, Leuven, Belgium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Kinshasa', 'class': 'OTHER'}, {'name': 'Yaounde Central Hospital', 'class': 'OTHER_GOV'}, {'name': 'University of Yaounde', 'class': 'OTHER'}, {'name': 'University of Libreville', 'class': 'UNKNOWN'}, {'name': 'Institute of Cardiology Abidjan', 'class': 'UNKNOWN'}, {'name': 'University of Ilorin Teaching Hospital', 'class': 'OTHER'}, {'name': 'University of Nigeria, Enugu Campus', 'class': 'OTHER'}, {'name': 'Hospital Aristide Le Dantec, Dakar, Senegal', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, MD, PhD', 'investigatorFullName': 'Jan A. Staessen', 'investigatorAffiliation': 'KU Leuven'}}}}