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

Hypertension Clinical Trial

— Creole  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742467
• Other study ID #: Project8264
• Status: Completed
• Phase: Phase 4
• Start date: June 7, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: August 2021
• Source: University of Abuja
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 702
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Perindopril plus Amlodipine
Group 1
• Perindopril plus Hydrochlorothiazide
Group 2
• Amlodipine plus Hydrochlorothiazide
Group 3

Locations

Country	Name	City	State
Nigeria	University of Abuja Teaching Hospital	Abuja	Federal Capital Territory

Sponsors (8)

Lead Sponsor	Collaborator
University of Abuja	Hôpital Edouard Herriot, Hospital General De Douala, Imperial College London, Mulago Hospital, Uganda, University College Hospital, Ibadan, University of Cape Town, University of Nairobi

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory blood pressure	Change in ambulatory systolic blood pressure measurement from baseline to 6 months from will be determined.	six months
Secondary	Assessment of ambulatory diastolic blood pressure	Change in 24 hour ambulatory diastolic blood pressure between randomisation and 6 months	six months
Secondary	Clinic systolic and diastolic blood pressure	Change in clinic systolic and diastolic blood pressure will be difference in values between randomisation and 6 months	Six months
Secondary	Night time and day time blood pressure	Change in daytime and night time blood pressure	Six months
Secondary	Blood pressure control	change in BP variability measured will be measured by ambulatory blood pressure	Six months
Secondary	Blood pressure control	Proportion of patients who achieve BP control (defined as clinic BP < 140/90 mmHg) after 6 months	Two months and six months
Secondary	Response to study medications	Proportion of "responders" (defined as clinic BP reduction > 20mmHg SBP and >10 mmHg DBP) from randomisation to 6 months	Two months and six months
Secondary	Change in values of micro- and macro-albuminuria	Change in micro- and macro-albuminuria will be measured from randomisation to 6 months	Six months
Secondary	Fasting blood sugar variation	Change in fasting blood sugar which will be from randomisation to 6 months	Six months
Secondary	Fasting lipid profile variation	Change in fasting lipid profile between from randomisation to 6 months	Six months