Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans (Creole)
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ClinicalTrials.gov Identifier: NCT02742467 |
Recruitment Status :
Completed
First Posted : April 19, 2016
Last Update Posted : August 24, 2021
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Condition or disease | Intervention/treatment | Phase |
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Hypertension | Drug: Perindopril plus Amlodipine Drug: Perindopril plus Hydrochlorothiazide Drug: Amlodipine plus Hydrochlorothiazide | Phase 4 |
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.
The 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 702 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans |
Actual Study Start Date : | June 7, 2017 |
Actual Primary Completion Date : | June 1, 2018 |
Actual Study Completion Date : | June 1, 2018 |

Arm | Intervention/treatment |
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Experimental: 1
Perindopril plus Amlodipine at a dose of 4mg/5mg once daily for two months and 8mg/10mg once daily for the remaining four months.
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Drug: Perindopril plus Hydrochlorothiazide
Group 2 Drug: Amlodipine plus Hydrochlorothiazide Group 3 |
Active Comparator: 2
Perindopril Plus Hydrochlorothiazide at a dose of 4mg/12.5mg and 8mg/25mg once daily for the remaining four months.
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Drug: Perindopril plus Amlodipine
Group 1 Drug: Amlodipine plus Hydrochlorothiazide Group 3 |
Active Comparator: 3
Amlodipine plus Hydrochlorothiazide 5mg/12.5mg for two months and 10mg/25mg for the remaining four months.
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Drug: Perindopril plus Amlodipine
Group 1 Drug: Perindopril plus Hydrochlorothiazide Group 2 |
- Ambulatory blood pressure [ Time Frame: six months ]Change in ambulatory systolic blood pressure measurement from baseline to 6 months from will be determined.
- Assessment of ambulatory diastolic blood pressure [ Time Frame: six months ]Change in 24 hour ambulatory diastolic blood pressure between randomisation and 6 months
- Clinic systolic and diastolic blood pressure [ Time Frame: Six months ]Change in clinic systolic and diastolic blood pressure will be difference in values between randomisation and 6 months
- Night time and day time blood pressure [ Time Frame: Six months ]Change in daytime and night time blood pressure
- Blood pressure control [ Time Frame: Six months ]change in BP variability measured will be measured by ambulatory blood pressure
- Blood pressure control [ Time Frame: Two months and six months ]Proportion of patients who achieve BP control (defined as clinic BP < 140/90 mmHg) after 6 months
- Response to study medications [ Time Frame: Two months and six months ]Proportion of "responders" (defined as clinic BP reduction > 20mmHg SBP and >10 mmHg DBP) from randomisation to 6 months
- Change in values of micro- and macro-albuminuria [ Time Frame: Six months ]Change in micro- and macro-albuminuria will be measured from randomisation to 6 months
- Fasting blood sugar variation [ Time Frame: Six months ]Change in fasting blood sugar which will be from randomisation to 6 months
- Fasting lipid profile variation [ Time Frame: Six months ]Change in fasting lipid profile between from randomisation to 6 months

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Ages Eligible for Study: | 30 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with Sitting SBP ≥140 mm Hg and < 160 mmHg on one antihypertensive agen or
- Sitting SBP ≥ 150 mm Hg and < 180 mm Hg on no antihypertensive treatment.
Exclusion Criteria:
- Congestive heart failure (clinically defined).
- Serum creatinine levels greater than 170 µmol/l or estimated glomerular filtration rate (eGFR) < 30 ml/min.
- History of coronary heart disease (i.e., chronic stable angina, myocardial infarction or acute coronary syndrome).
- History of a stroke or other cerebrovascular accident (i.e. transient ischaemic attack or reversible ischaemic neurological deficit).
- Known or suspected secondary hypertension.
- Any other concomitant illness, physical or mental impairment that could interfere with the effective conduct of the study.
- Pregnancy or those of child-bearing age who are not taking reliable contraception.
- Patients with a history of intolerance to any of the study medications for example angioedema or dry cough with angiotensin converting enzyme inhibitors.
- 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)
- Gout.
- Serum potassium < 3.5mmol/L at screening.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742467
Nigeria | |
University of Abuja Teaching Hospital | |
Abuja, Federal Capital Territory, Nigeria, 90001 |
Study Director: | Neil Poulter, MD, MSc | Imperial College London | |
Study Chair: | Bongani Mayosi, DPhil | University of Cape Town |
Responsible Party: | Dr. Dike Ojji, Dr, University of Abuja |
ClinicalTrials.gov Identifier: | NCT02742467 |
Other Study ID Numbers: |
Project8264 |
First Posted: | April 19, 2016 Key Record Dates |
Last Update Posted: | August 24, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Hydrochlorothiazide Perindopril Antihypertensive Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Diuretics Natriuretic Agents Sodium Chloride Symporter Inhibitors Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors |