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

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Abuja
• Collaborators: Hôpital Edouard Herriot; Hospital General De Douala; Imperial College London; Mulago Hospital, Uganda; University College Hospital, Ibadan; University of Cape Town; University of Ibadan; University of Nairobi
• Treatments: Amlodipine; Hydrochlorothiazide; Perindopril

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.