NCT04518306

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

Efficacy and Safety of GMRx2 (a Single Pill Combination Containing Telmisartan/Amlodipine/Indapamide) Compared to Placebo for the Treatment of Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 755 (actual)
• Sponsor: George Medicines PTY Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

TRIAL DRUG: GMRx2: single pill combination of telmisartan/amlodipine/indapamide Dose version 1: telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Dose version 2: telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg INDICATION: Hypertension TRIAL TITLE: Efficacy and safety of GMRx2 compared to placebo for the treatment of hypertension. OBJECTIVES: To investigate the efficacy and safety of GMRx2 compared to placebo for the treatment of hypertension. INTERVENTION: A 2-week single-blind placebo run-in will be followed by a 4-week double-blind period with randomization to GMRx2 dose version 1, GMRx2 dose version 2 or placebo.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg	Oral tablets
DRUG	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg	Oral tablets
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-06-14
• Primary completion: 2023-09-19
• Completion: 2023-10-18
• First posted: 2020-08-19
• Last updated: 2025-06-03
• Results posted: 2025-06-03

Locations

47 sites across 5 countries: United States, Australia, Nigeria, Sri Lanka, United Kingdom

Regulatory

• FDA-regulated drug study