NCT05683301

Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,981 (actual)
• Sponsor: Centre for Chronic Disease Control, India · Academic / Other
• Sex: All
• Age: 30 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Primary Hypertension

Interventions

Type	Name	Description
DRUG	Amlodipine + Perindopril	Single pill combination of dual antihypertensive agent
DRUG	Perindopril + Indapamide	Single pill combination of dual antihypertensive agent
DRUG	Amlodipine + Indapamide	Single pill combination of dual antihypertensive agent

Timeline

• Start date: 2022-08-30
• Primary completion: 2024-08-30
• Completion: 2024-09-22
• First posted: 2023-01-13
• Last updated: 2024-10-08

Locations

35 sites across 1 country: India