Hypertension
Conditions
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.
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.
Interventions
DRUGPerindopril plus Amlodipine
Group 1
DRUGPerindopril plus Hydrochlorothiazide
Group 2
DRUGAmlodipine plus Hydrochlorothiazide
Group 3
Sponsors
Imperial College London
University of Cape Town
Hôpital Edouard Herriot
University of Nairobi
University College Hospital, Ibadan
Hospital General De Douala
Mulago Hospital, Uganda
University of Abuja
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ambulatory blood pressure | six months | Change in ambulatory systolic blood pressure measurement from baseline to 6 months from will be determined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinic systolic and diastolic blood pressure | Six months | Change in clinic systolic and diastolic blood pressure will be difference in values between randomisation and 6 months |
| Night time and day time blood pressure | Six months | Change in daytime and night time blood pressure |
| Blood pressure control | Six months | change in BP variability measured will be measured by ambulatory blood pressure |
| Assessment of ambulatory diastolic blood pressure | six months | Change in 24 hour ambulatory diastolic blood pressure between randomisation and 6 months |
| Change in values of micro- and macro-albuminuria | Six months | Change in micro- and macro-albuminuria will be measured from randomisation to 6 months |
| Fasting blood sugar variation | Six months | Change in fasting blood sugar which will be from randomisation to 6 months |
| Fasting lipid profile variation | Six months | Change in fasting lipid profile between from randomisation to 6 months |
| Response to study medications | Two months and six months | Proportion of responders (defined as clinic BP reduction \> 20mmHg SBP and \>10 mmHg DBP) from randomisation to 6 months |
Countries
Nigeria
Outcome results
None listed