To study the effectiveness, safety and tolerability of Fixed Dose Combination of Perindopril plus Indapamide plus Amlodipine in the treatment of hypertension.
- Conditions
- Health Condition 1: I10- Essential (primary) hypertensionHealth Condition 2: null- GRADE II/III HYPERTENSIO
- Registration Number
- CTRI/2017/09/009786
- Lead Sponsor
- Serdia Pharmaceuticals India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 240
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: Day 15 and Day 180
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of TRIPLIXAM® in the treatment of hypertension <br/ ><br> <br/ ><br>Timepoint: Day 180;To evaluate the quality of life (QoL) in patients treated with TRIPLIXAM® treatment using WHO QoL tool questionnaire. (WHOQOL-BREF 26-point questionnaire)Timepoint: Day 180