To study the effectiveness, safety and tolerability of Fixed Dose Combination of Perindopril plus Indapamide plus Amlodipine in the treatment of hypertension.

Efficacy and tolerability of Fixed Dose Combination of Perindopril plus Indapamide plus Amlodipine in patients with grade II/III hypertension

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/09/009786

Enrollment

240

Registered

2017-09-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I10- Essential (primary) hypertension Health Condition 2: null- GRADE II/III HYPERTENSION

Interventions

Intervention1: A fixed dose combination of perindopril indapamide and amlodipine (Brand name TRIPLIXAM®): 2 strengths of FDC Perindopril erbumine 4 mg indapamide 1.25 mg and amlodipine 5 mg AND Per

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To assess the safety and tolerability of TRIPLIXAM® in the treatment of hypertension 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	—

Countries

India

Contacts

Public ContactSOFI JOSEPH

Serdia Pharmaceuticals (India) Pvt. Ltd

sofi.joseph@servier.com91-022-24196000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026