Efficacy and Safety of GMRx2 Compared to Placebo for the Treatment of Hypertension

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

Outcome

Met primary endpoint

registry analysis (superiority test); Triple ¼ (GMRx2) vs Placebo; p <0.0001; LS Means Difference -7.33 (95% CI -10.176 to -4.486); NCT04518306 ↗

registry analysis (superiority test); Triple ½ (GMRx2) vs Placebo; p <0.0001; LS Means Difference -8.23 (95% CI -11.305 to -5.151); NCT04518306 ↗

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

Indications