Evaluation of the Clinical Efficacy and Safety of Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg Fixed Combination in Single-pill After 2 Months of Treatment Versus Free Combination, Perindopril 4 mg / Indapamide 1.25 mg + Amlodipine 5 mg Given Separately at the Same Time, With Conditional Titration Based on Blood Pressure Control in Patients With Essential Hypertension Uncontrolled After 1 Month With Perindopril 4 mg / Indapamide 1.25 mg Bi-therapy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 532
- 试验地点
- 42
- 主要终点
- Sitting SBP change after two months of treatment
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of a fixed-dose combination of perindopril 5 mg /indapamide 1.25 mg / amlodipine 5 mg compared to the free combination of the same components (perindopril 4 mg / indapamide 1.25 mg in a single pill and amlodipine 5 mg pill given separately at the same time) in chinese patients with uncontrolled essential hypertension.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women of Asian origin
- •≥18 years old
- •Treated for essential hypertension
- •Having the day of the selection visit an uncontrolled hypertension treated with any anti-hypertensive monotherapy at maximal dose or any dual therapy at starting dose according to investigator's routine practice or at least 1 month prior to the visit
- •Having at the selection visit a sitting SBP≥140 and <180 mmHg and DBP≥90 and <110 mmHg
排除标准
- •Known or suspected symptomatic orthostatic hypotension or positive orthostatic test at the selection visit
- •Treatment with more than 2 antihypertensive drugs or with 2 antihypertensive drugs at the highest doses at the selection visit
研究组 & 干预措施
Fixed [Per/Ind/Aml]
From inclusion to Month 2, patients receive the fixed combination of perindopril 5 mg / indapamide 1.25 mg / amlodipine 5 mg (S06593).
From Month 2 to 4, patients either stay at the same dose if the blood pressure is controlled, either are up-titrated to the next dose of the strategy if the blood pressure is not controlled (ie, perindopril 10 mg / indapamide 2.5 mg / amlodipine 5 mg).
From Month 4 to 6, patients either stay at the same dose if the blood pressure is controlled, either are up-titrated to the next dose of the strategy if the blood pressure is not controlled (ie, for patients who were up-titrated at Month 2 visit: perindopril 10 mg / indapamide 2.5 mg / amlodipine 10 mg or for patients who were not yet up-titrated: perindopril 10 mg / indapamide 2.5 mg / amlodipine 5 mg.
干预措施: Fixed [Per/Ind/Aml] (Drug)
Free [Per/Ind + Aml]
From inclusion to Month 2, patients receive the free combination of perindopril 4 mg / indapamide 1.25 mg plus amlodipine 5 mg.
From Month 2 to 4, patients either stay at the same dose if the blood pressure is controlled, either are up-titrated to the next dose of the strategy if the blood pressure is not controlled (ie, double dose of perindopril 4 mg / indapamide 1.25 mg plus amlodipine 5 mg for patients).
From Month 4 to 6, patients either stay at the same dose if the blood pressure is controlled, either are up-titrated to the next dose of the strategy if the blood pressure is not controlled (ie for patients who were up-titrated at Month 2 visit: double dose of perindopril 4 mg / indapamide 1.25 mg plus double dose of amlodipine 5 mg or for patients who were not yet up-titrated:double dose of perindopril 4 mg / indapamide 1.25 mg plus amlodipine 5 mg.
干预措施: Free [Per/Ind + Aml] (Drug)
结局指标
主要结局
Sitting SBP change after two months of treatment
时间窗: Baseline safety visit, Month 2 follow-up visit
Office sitting Systolic Blood Pressure (SBP) change from baseline to last post-baseline value over the period from Month 0 to month 2
次要结局
- Sitting DBP change after two months of treatment(Baseline safety visit, Month 2 follow-up visit)
- Sitting DBP change from month 4 to month 6(Month 4 follow-up visit, Month 6 follow-up visit)
- Sitting SBP change from month 4 to month 6(Month 4 follow-up visit, Month 6 follow-up visit)
- Sitting DBP change from month 2 to month 4(Month 2 follow-up visit, Month 4 follow-up visit)
- Sitting Pulse Pressure change after two months of treatment(Baseline safety visit, Month 2 follow-up visit)
- Sitting SBP change from month 2 to month 4(Month 2 follow-up visit, Month 4 follow-up visit)
- Sitting Mean Arterial Pressure change from month 2 to month 4(Month 2 follow-up visit, Month 4 follow-up visit)
- Adverse events between Month 0 and Month 2(Up to the 2 month follow-up visit)
- Adverse events between Month 0 and Month 6(Up to the 6 month final visit)
- Sitting Mean Arterial Pressure change after two months of treatment(Baseline safety visit, Month 2 follow-up visit)
- Sitting Mean Arterial Pressure change from month 4 to month 6(Month 4 follow-up visit, Month 6 follow-up visit)
- Response to the treatment at two months(Month 2 follow-up visit)
- Control of Blood Pressure at two months(Month 2 follow-up visit)