Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

702 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-07

Study Completion Date

2018-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Perindopril plus Hydrochlorothiazide

Intervention Type DRUG

Group 2

Amlodipine plus Hydrochlorothiazide

Intervention Type DRUG

Group 3

2

Perindopril Plus Hydrochlorothiazide at a dose of 4mg/12.5mg and 8mg/25mg once daily for the remaining four months.

Group Type ACTIVE_COMPARATOR

Perindopril plus Amlodipine

Intervention Type DRUG

Group 1

Amlodipine plus Hydrochlorothiazide

Intervention Type DRUG

Group 3

3

Amlodipine plus Hydrochlorothiazide 5mg/12.5mg for two months and 10mg/25mg for the remaining four months.

Group Type ACTIVE_COMPARATOR

Perindopril plus Amlodipine

Intervention Type DRUG

Group 1

Perindopril plus Hydrochlorothiazide

Intervention Type DRUG

Group 2

Interventions

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Perindopril plus Amlodipine

Group 1

Intervention Type DRUG

Perindopril plus Hydrochlorothiazide

Group 2

Intervention Type DRUG

Amlodipine plus Hydrochlorothiazide

Group 3

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No