drugset / Trial / NCT04518306
Efficacy and Safety of GMRx2 Compared to Placebo for the Treatment of Hypertension
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients. Several trials suggest triple low-dose combination therapy may be highly effective in terms of achieving blood pressure control without increasing adverse effects. This trial is designed to investigate the efficacy and safety of GMRx2 in participants with high blood pressure compared to placebo.
Timeline
- Start
- 2021-06-14
- Primary completion
- 2023-09-19
- Completion
- 2023-10-18
Publications
- Salam A, de Silva HA, Ojji D, de Silva AP, Galappatthy G, Lakshman P, Kumanan T, Mayurathan G, Pereira T, Rahuman M, Ranasinghe G, Rasnayake L, Uluwattage W, Constantine GR, Kandeepan T, Sani MU, Kumar A, Pant R, Cushman WC, Di Tanna GL, Grobbee D, Narkiewicz K, Oparil S, Poulter NR, Schlaich MP, Schutte AE, Spiering W, Williams B, Wright JT Jr, Gianacas C, Shanthakumar M, Liu X, Freed R, Whelton PK, Rodgers A. Long-Term Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination for the Treatment of Hypertension. Glob Heart. 2025 Oct 31;20(1):102. doi: 10.5334/gh.1481. eCollection 2025.
- Rodgers A, Salam A, Schutte AE, Cushman WC, de Silva HA, Di Tanna GL, Grobbee D, Narkiewicz K, Ojji DB, Poulter NR, Schlaich MP, Oparil S, Spiering W, Williams B, Wright JT Jr, Gutierez A, Sanni A, Lakshman P, McMullen D, Ranasinghe G, Gianacas C, Shanthakumar M, Liu X, Wang N, Whelton P. Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination Compared With Placebo for Initial Treatment of Hypertension. J Am Coll Cardiol. 2024 Dec 10;84(24):2393-2403. doi: 10.1016/j.jacc.2024.08.025. Epub 2024 Aug 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | 1.25 mg | Oral |
| Subject | Amlodipine | Other / unclassified | 2.5 mg | Oral |
| Subject | Indapamide | Small molecule | 0.625 mg | Oral |
| Subject | Indapamide | Small molecule | 1.25 mg | Oral |
| Subject | Telmisartan | Other / unclassified | 10 mg | Oral |
| Subject | Telmisartan | Other / unclassified | 20 mg | Oral |