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Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans (Creole)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02742467
Recruitment Status : Completed
First Posted : April 19, 2016
Last Update Posted : July 27, 2018
Sponsor:
Collaborators:
Imperial College London
University of Cape Town
Hôpital Edouard Herriot
University of Nairobi
University College Hospital, Ibadan
Hospital General De Douala
Mulago Hospital, Uganda
Information provided by (Responsible Party):
Dr. Dike Ojji, University of Abuja

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Perindopril plus Amlodipine Drug: Perindopril plus Hydrochlorothiazide Drug: Amlodipine plus Hydrochlorothiazide Phase 4

Detailed Description:

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.

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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 : May 15, 2018
Actual Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
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.
Drug: Perindopril plus Amlodipine
Group 1

Drug: Perindopril plus Hydrochlorothiazide
Group 2




Primary Outcome Measures :
  1. Ambulatory blood pressure [ Time Frame: six months ]
    Change in ambulatory systolic blood pressure measurement from baseline to 6 months from will be determined.


Secondary Outcome Measures :
  1. Assessment of ambulatory diastolic blood pressure [ Time Frame: six months ]
    Change in 24 hour ambulatory diastolic blood pressure between randomisation and 6 months

  2. 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

  3. Night time and day time blood pressure [ Time Frame: Six months ]
    Change in daytime and night time blood pressure

  4. Blood pressure control [ Time Frame: Six months ]
    change in BP variability measured will be measured by ambulatory blood pressure

  5. 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

  6. 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

  7. 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

  8. Fasting blood sugar variation [ Time Frame: Six months ]
    Change in fasting blood sugar which will be from randomisation to 6 months

  9. Fasting lipid profile variation [ Time Frame: Six months ]
    Change in fasting lipid profile between from randomisation to 6 months



Information from the National Library of Medicine

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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
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Nigeria
University of Abuja Teaching Hospital
Abuja, Federal Capital Territory, Nigeria, 90001
Sponsors and Collaborators
University of Abuja
Imperial College London
University of Cape Town
Hôpital Edouard Herriot
University of Nairobi
University College Hospital, Ibadan
Hospital General De Douala
Mulago Hospital, Uganda
Investigators
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Study Director: Neil Poulter, MD, MSc Imperial College London
Study Chair: Bongani Mayosi, DPhil University of Cape Town

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: July 27, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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