Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 702
- 试验地点
- 1
- 主要终点
- Ambulatory blood pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
- •Serum potassium < 3.5mmol/L at screening.
研究组 & 干预措施
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.
干预措施: Amlodipine plus Hydrochlorothiazide (Drug)
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.
干预措施: Perindopril plus Hydrochlorothiazide (Drug)
2
Perindopril Plus Hydrochlorothiazide at a dose of 4mg/12.5mg and 8mg/25mg once daily for the remaining four months.
干预措施: Perindopril plus Amlodipine (Drug)
2
Perindopril Plus Hydrochlorothiazide at a dose of 4mg/12.5mg and 8mg/25mg once daily for the remaining four months.
干预措施: Amlodipine plus Hydrochlorothiazide (Drug)
3
Amlodipine plus Hydrochlorothiazide 5mg/12.5mg for two months and 10mg/25mg for the remaining four months.
干预措施: Perindopril plus Amlodipine (Drug)
3
Amlodipine plus Hydrochlorothiazide 5mg/12.5mg for two months and 10mg/25mg for the remaining four months.
干预措施: Perindopril plus Hydrochlorothiazide (Drug)
结局指标
主要结局
Ambulatory blood pressure
时间窗: six months
Change in ambulatory systolic blood pressure measurement from baseline to 6 months from will be determined.
次要结局
- Change in values of micro- and macro-albuminuria(Six months)
- Fasting blood sugar variation(Six months)
- Clinic systolic and diastolic blood pressure(Six months)
- Assessment of ambulatory diastolic blood pressure(six months)
- Blood pressure control(Two months and six months)
- Response to study medications(Two months and six months)
- Fasting lipid profile variation(Six months)
- Night time and day time blood pressure(Six months)