drugset / Trial / NCT05683301
Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India
Phase 4
Completed
1981 enrolled
Centre for Chronic Disease Control, India
All India Institute of Medical Sciences · collabImperial College London · collab
RandomizedParallel-groupQuadruple-blindOther
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
Timeline
- Start
- 2022-08-30
- Primary completion
- 2024-08-30
- Completion
- 2024-09-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | 10 mg | Oral |
| Subject | Indapamide | Small molecule | 1.5 mg | Oral |
| Subject | Indapamide | Small molecule | 2.5 mg | Oral |
| Subject | Perindopril | Small molecule | 8 mg | Oral |