Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,981
- 试验地点
- 31
- 主要终点
- 24-hour ambulatory systolic Blood Pressure
研究概览
简要总结
Hypertension is a leading cause of morbidity and mortality globally. Although multiple drugs are frequently used to treat it, in the South Asian context, evidence is lacking on best drug combinations. This trial aims to compare efficacy of three single-pill combinations of two anti-hypertensive agents on 24-hour ambulatory systolic blood pressure among 1968 individuals with hypertension. The trial is a single-blind randomized controlled trial spread across 37 hospitals in India.
Single Pill combinations (SPCs): 1) Amlodipine + Perindopril, 2) Perindopril + Indapamide, 3) Amlodipine + Indapamide
详细描述
This is a multi-centre, individual randomized single-blind, parallel group, three-armed superiority trial to compare the efficacy of three different single-pill combinations of antihypertensive therapies (Amlodipine/Perindopril, Perindopril/Indapamide, and Amlodipine/Indapamide)on 24-hour ambulatory BP levels in Indians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age 30-79 years AND
- •Sitting clinic values* of SBP ≥140 mmHg and <160 mmHg on one antihypertensive agent OR
- •Sitting clinic values* of SBP ≥150 mmHg and <180 mmHg on no antihypertensive treatment * Mean of the last 2 of 3 readings.
排除标准
- •Congestive heart failure (clinically defined).
- •Patients with a history of intolerance to any of the study medications for example angioedema or dry cough with Angiotensin-converting enzyme inhibitors.
- •Serum creatinine levels greater than 132.6µmol/l (1.5mg/dl)
- •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).
- •Severe hepatic impairment
- •Treatment with agents causing torsades de pointes
- •Contraindications to any of the investigational medicinal products as per the summaries product characteristics of drugs studied
- •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.
- •History of Gout.
- •Serum potassium < 3.5mmol/L at screening.
研究组 & 干预措施
Arm 1
(Arm 1 compare to Arm 2 compare to Arm 3) - Treatment Period 1 (Enrollment - 2 months) - Single Pill Combination of Amlodipine 5 mg and Perindopril 4 mg once daily, orally Treatment Period 2 (2 months - 6 months) - Single Pill Combination of Amlodipine 10 mg and Perindopril 8 mg once daily, orally
干预措施: Amlodipine + Perindopril (Drug)
Arm 2
(Arm 1 compare to Arm 2 compare to Arm 3) - Treatment Period 1 (Enrollment - 2 months) - Single Pill Combination of Perindopril 4 mg and Indapamide 1.25 mg once daily, orally Treatment Period 2 (2 months - 6 months) - Single Pill Combination of Perindopril 8 mg and Indapamide 2.5 mg once daily, orally
干预措施: Perindopril + Indapamide (Drug)
Arm 3
(Arm 1 compare to Arm 2 compare to Arm 3) - Treatment Period 1 (Enrollment - 2 months) - Single Pill Combination of Amlodipine 5 mg and Indapamide 1.5 mg sustained release once daily, orally Treatment Period 2 (2 months - 6 months) - Single Pill Combination of Amlodipine 10 mg and Indapamide 1.5 mg sustained release once daily, orally
干预措施: Amlodipine + Indapamide (Drug)
结局指标
主要结局
24-hour ambulatory systolic Blood Pressure
时间窗: Change in between baseline and 6 month Ambulatory Systolic Blood Pressure
To determine which of three single pill combinations of two anti-hypertensive agents is most effective in reducing 24-hour ambulatory systolic BP (ASBP) in Indian patients with hypertension.
次要结局
- Serum creatinine(Change in serum creatinine measured at baseline and 6 month)
- eGFR(Change in eGFR measured at baseline and 6 month)
- renin and aldosterone(Change in plasme renin and/or aldosterone measured at baseline and 6 month)
- Serum potassium(Change in serum potassium measured at baseline and 6 month)
- Serum urea(Change in serum urea measured at baseline and 6 month)
- 24-hour ambulatory diastolic blood pressure(Change in between baseline and 6 month Ambulatory Diastolic Blood Pressure)
- Clinic Blood Pressure(Comparison of Clinic blood pressure measured at baseline 2 month , 4 month and 6 month)
- Daytime and nighttime Blood Pressure(Change in between baseline and 6 month ASBP and ADBP)
- BP variability measured by ABPM and within-visit clinic BPs(Fluctuations in Ambulatory blood pressures as measured at baseline and 6 month and fluctuation in Clinic BP as measured at baseline, 2 month, 4 month and 6 month)
- Micro- and macro-albuminuria(Change in serum albumin measured at baseline and 6 month)
- Proportion of patients who achieve BP control(BP control measured in Clinic BP as measured at baseline, 2 month, 4 month and 6 month and ABP measured at baseline and 6 month)
- Proportion of patients classified as "responders"(Clinic BP as measured at baseline, 2 month, 4 month and 6 month)
- Fasting blood glucose(Change in fasting blood glucose measured at baseline and 6 month)
- Serum sodium(Change in serum sodium measured at baseline and 6 month)
- Adverse events causing trial withdrawal(adverse events causing withdrawal at 2 month, 4 month and 6 month)
- Fasting lipid profile(Change in serum lipid profile measured at baseline and 6 month)
研究者
Dr. Dorairaj Prabhakaran
Executive Director
Centre for Chronic Disease Control, India