Efficacy and tolerability of Fixed Dose Combination of Perindopril plus Indapamide plus Amlodipine in patients with grade II/III hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 5
- 主要终点
- To assess the blood pressure reduction rate in moderate to severe hypertensive patients after treatment with TRIPLIXAM® given once daily in the morning during the study evaluation period.
研究概览
简要总结
The study will be conducted as per the GCP guidelines and the "Ethical Guidelines for Biomedical Research on Human Participants" issued by ICMR and the other regulations in force in India.
The Fixed Dose Combination of perindopril + indapamide + amlodipine, three drugs in a fixed dose combination (FDC) is recently approved in Europe. It is indicated for the treatment of essential hypertension where combination treatment for target blood pressure is recommended. The proposed phase III study is a part of the marketing approval review process in India.
The sponsor of the study M/S Serdia Pharmaceuticals (India) Pvt. Ltd wishes to introduce a fixed dose combination with these three widely used antihypertensive drugs from three different therapeutic classes in the following composition:
- perindopril erbumine 4 mg + indapamide 1.25 mg + amlodipine 5 mg
- perindopril erbumine 8 mg + indapamide 1.25mg + amlodipine 5 mg240 patients (35 patients per centre) will be included in the study satisfying the eligibility criteria as per the protocol, with an objective to obtain at least 200 patients completing the study from 5 centres.
Scheduled date of start: Sep 2017 (tentative)
Scheduled date of completion: May 2019 (tentative)
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Uncontrolled grade II and grade III hypertensive patients with a baseline blood pressure > 140/90 mmHg despite receiving any two drug therapy comprising of either ACEI, ARBs, CCBs and diuretics as individual tablets or in combination as a fixed dose combination therapy 2.Patients of either sex 3.With confirmed diagnosis of Grade II/ III (moderate to severe) hypertension, as per ESC 2013 guidelines.
排除标准
- •1.Uncontrolled diabetes (Hba1c% more than 7) 2.H/o myocardial infarction within the previous 3 months 3.H/o cerebrovascular event within previous 3 months 4.Uncontrolled arrhythmias 5.H/o Heart failure 6.Patients with class II/IV heart blocks 7.Patients receiving beta-blockers 8.Patients with known severe impaired renal function (serum creatinine levels 5.3 mg/dl and / or serious liver disorders) 9.Patients unwilling to give informed consent.
- •10.Patients with known history of hypersensitivity to indapamide or amlodipine or perindopril 11.Any contraindication to Thiazide type diuretic, CCB and ACEI 12.Pregnancy or lactation 13.Patients with any other condition or disease, which in opinion of the investigator could preclude evaluation of response to study medication or hamper the safety of the trial participant.
- •14.Patients previously enrolled in similar or any other trial in the preceding last 6 months.
结局指标
主要结局
To assess the blood pressure reduction rate in moderate to severe hypertensive patients after treatment with TRIPLIXAM® given once daily in the morning during the study evaluation period.
时间窗: Day 15 and Day 180
次要结局
- To assess the safety and tolerability of TRIPLIXAM® in the treatment of hypertension
- To evaluate the quality of life (QoL) in patients treated with TRIPLIXAM® treatment using WHO QoL tool questionnaire. (WHOQOL-BREF 26-point questionnaire)(Day 180)