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

NCT05683301 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1981

Last updated 2024-10-08

No results posted yet for this study

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

Conditions

  • Primary Hypertension

Interventions

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

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    collaborator OTHER

  • Imperial College London

    collaborator OTHER

  • Centre for Chronic Disease Control, India

    lead OTHER

Principal Investigators

  • Dorairaj Prabhakaran, DM Cardiology · Centre for Chronic Disease Control, New Delhi

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-30
Primary Completion
2024-08-30
Completion
2024-09-22

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05683301 on ClinicalTrials.gov