Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-22 @ 5:22 PM
Study NCT ID:
NCT02742467
Status:
COMPLETED
Last Update Posted:
2021-08-24
First Post:
2016-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D020913', 'term': 'Perindopril'}, {'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 702}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2016-04-14', 'studyFirstSubmitQcDate': '2016-04-18', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ambulatory blood pressure', 'timeFrame': 'six months', 'description': 'Change in ambulatory systolic blood pressure measurement from baseline to 6 months from will be determined.'}], 'secondaryOutcomes': [{'measure': 'Assessment of ambulatory diastolic blood pressure', 'timeFrame': 'six months', 'description': 'Change in 24 hour ambulatory diastolic blood pressure between randomisation and 6 months'}, {'measure': 'Clinic systolic and diastolic blood pressure', 'timeFrame': 'Six months', 'description': 'Change in clinic systolic and diastolic blood pressure will be difference in values between randomisation and 6 months'}, {'measure': 'Night time and day time blood pressure', 'timeFrame': 'Six months', 'description': 'Change in daytime and night time blood pressure'}, {'measure': 'Blood pressure control', 'timeFrame': 'Six months', 'description': 'change in BP variability measured will be measured by ambulatory blood pressure'}, {'measure': 'Blood pressure control', 'timeFrame': 'Two months and six months', 'description': 'Proportion of patients who achieve BP control (defined as clinic BP \\< 140/90 mmHg) after 6 months'}, {'measure': 'Response to study medications', 'timeFrame': 'Two months and six months', 'description': 'Proportion of "responders" (defined as clinic BP reduction \\> 20mmHg SBP and \\>10 mmHg DBP) from randomisation to 6 months'}, {'measure': 'Change in values of micro- and macro-albuminuria', 'timeFrame': 'Six months', 'description': 'Change in micro- and macro-albuminuria will be measured from randomisation to 6 months'}, {'measure': 'Fasting blood sugar variation', 'timeFrame': 'Six months', 'description': 'Change in fasting blood sugar which will be from randomisation to 6 months'}, {'measure': 'Fasting lipid profile variation', 'timeFrame': 'Six months', 'description': 'Change in fasting lipid profile between from randomisation to 6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '34022790', 'type': 'DERIVED', 'citation': 'Ingabire PM, Ojji DB, Rayner B, Ogola E, Damasceno A, Jones E, Dzudie A, Ogah OS, Poulter N, Sani MU, Barasa FA, Shedul G, Mukisa J, Mukunya D, Wandera B, Batte C, Kayima J, Pandie S, Mondo CK; CREOLE Study Investigators. High prevalence of non-dipping patterns among Black Africans with uncontrolled hypertension: a secondary analysis of the CREOLE trial. BMC Cardiovasc Disord. 2021 May 22;21(1):254. doi: 10.1186/s12872-021-02074-7.'}, {'pmid': '30883050', 'type': 'DERIVED', 'citation': 'Ojji DB, Mayosi B, Francis V, Badri M, Cornelius V, Smythe W, Kramer N, Barasa F, Damasceno A, Dzudie A, Jones E, Mondo C, Ogah O, Ogola E, Sani MU, Shedul GL, Shedul G, Rayner B, Okpechi IG, Sliwa K, Poulter N; CREOLE Study Investigators. Comparison of Dual Therapies for Lowering Blood Pressure in Black Africans. N Engl J Med. 2019 Jun 20;380(25):2429-2439. doi: 10.1056/NEJMoa1901113. Epub 2019 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'The creole study is a A Multi-centre, multinational, randomised single-blind, parallel group, three-armed superiority trial which is aimed at comparing the efficacy of three "free" combinations of two anti-hypertensive agents on 24 hour ambulatory systolic blood pressure (ASBP) in black African hypertensive patients.', 'detailedDescription': 'The CREOLE trial will be performed at ten investigational sites in six countries in Sub-Saharan Africa which include Cameroun, Kenya, Mozambique, Nigeria, South Africa and Uganda. Subjects will be randomised to one of three treatments which are Perindopril plus Amlodipine or Perindopril plus Hydrochlorothiazide or Amlodipine plus Hydrochlorothiazide.Patients will commence treatment at a starting dose of Amlodipine plus Hydrochlorothiazide 5/12.5 mg or Amlodipine plus Perindopril 5/4 mg or Perindopril/Hydrochlorothiazide 4/12.5 mg. These doses will increase at the two months visit, to Amlodipine/Hydrochlorothiazide 10/25 mg or AmlodipinePperindopril 10/8mg or Perindopril/Hydrochlorothiazide 8/25 mg.\n\nThe patients will have ambulatory blood pressure monitoring at randomization and at six months and office blood pressure measurements at randomization and at two-month, 4-month and six-month visits.The overall aim is to discover the best combination of front-line anti-hypertensive medications for black patients residing in sub-Saharan Africa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Sitting SBP ≥140 mm Hg and \\< 160 mmHg on one antihypertensive agen or\n* Sitting SBP ≥ 150 mm Hg and \\< 180 mm Hg on no antihypertensive treatment.\n\nExclusion Criteria:\n\n* Congestive heart failure (clinically defined).\n* Serum creatinine levels greater than 170 µmol/l or estimated glomerular filtration rate (eGFR) \\< 30 ml/min.\n* History of coronary heart disease (i.e., chronic stable angina, myocardial infarction or acute coronary syndrome).\n* History of a stroke or other cerebrovascular accident (i.e. transient ischaemic attack or reversible ischaemic neurological deficit).\n* Known or suspected secondary hypertension.\n* Any other concomitant illness, physical or mental impairment that could interfere with the effective conduct of the study.\n* Pregnancy or those of child-bearing age who are not taking reliable contraception.\n* Patients with a history of intolerance to any of the study medications for example angioedema or dry cough with angiotensin converting enzyme inhibitors.\n* Patients on maximum dose of any of the study medications as monotherapy (i.e. amlodipine 10 mg/day or hydrochlorothiazide 25 mg/day or perindopril 8 mg/day)\n* Gout.\n* Serum potassium \\< 3.5mmol/L at screening.'}, 'identificationModule': {'nctId': 'NCT02742467', 'acronym': 'Creole', 'briefTitle': 'Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans', 'organization': {'class': 'OTHER', 'fullName': 'University of Abuja'}, 'officialTitle': 'Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans', 'orgStudyIdInfo': {'id': 'Project8264'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Perindopril plus Amlodipine at a dose of 4mg/5mg once daily for two months and 8mg/10mg once daily for the remaining four months.', 'interventionNames': ['Drug: Perindopril plus Hydrochlorothiazide', 'Drug: Amlodipine plus Hydrochlorothiazide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Perindopril Plus Hydrochlorothiazide at a dose of 4mg/12.5mg and 8mg/25mg once daily for the remaining four months.', 'interventionNames': ['Drug: Perindopril plus Amlodipine', 'Drug: Amlodipine plus Hydrochlorothiazide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Amlodipine plus Hydrochlorothiazide 5mg/12.5mg for two months and 10mg/25mg for the remaining four months.', 'interventionNames': ['Drug: Perindopril plus Amlodipine', 'Drug: Perindopril plus Hydrochlorothiazide']}], 'interventions': [{'name': 'Perindopril plus Amlodipine', 'type': 'DRUG', 'description': 'Group 1', 'armGroupLabels': ['2', '3']}, {'name': 'Perindopril plus Hydrochlorothiazide', 'type': 'DRUG', 'description': 'Group 2', 'armGroupLabels': ['1', '3']}, {'name': 'Amlodipine plus Hydrochlorothiazide', 'type': 'DRUG', 'description': 'Group 3', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90001', 'city': 'Abuja', 'state': 'Federal Capital Territory', 'country': 'Nigeria', 'facility': 'University of Abuja Teaching Hospital', 'geoPoint': {'lat': 9.05785, 'lon': 7.49508}}], 'overallOfficials': [{'name': 'Neil Poulter, MD, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Imperial College London'}, {'name': 'Bongani Mayosi, DPhil', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Cape Town'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Abuja', 'class': 'OTHER'}, 'collaborators': [{'name': 'Imperial College London', 'class': 'OTHER'}, {'name': 'University of Cape Town', 'class': 'OTHER'}, {'name': 'Hôpital Edouard Herriot', 'class': 'OTHER'}, {'name': 'University of Nairobi', 'class': 'OTHER'}, {'name': 'University College Hospital, Ibadan', 'class': 'OTHER'}, {'name': 'Hospital General De Douala', 'class': 'OTHER'}, {'name': 'Mulago Hospital, Uganda', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Dr. Dike Ojji', 'investigatorAffiliation': 'University of Abuja'}}}}