NCT02742467

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 702 (actual)
• Sponsor: University of Abuja · Academic / Other
• Sex: All
• Age: 30 Years – 79 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Perindopril plus Amlodipine	Group 1
DRUG	Perindopril plus Hydrochlorothiazide	Group 2
DRUG	Amlodipine plus Hydrochlorothiazide	Group 3

Timeline

• Start date: 2017-06-07
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2016-04-19
• Last updated: 2021-08-24

Locations

1 site across 1 country: Nigeria