NCT04518293

Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,385 (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 (BP) 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 dual combinations.

Detailed description

TRIAL DRUG: GMRx2: Single pill combinations of telmisartan/amlodipine/indapamide Dose version 2: telmisartan 20mg/amlodipine 2.5mg/indapamide 1.25mg Dose version 3: telmisartan 40mg/amlodipine 5 mg/indapamide 2.5mg INDICATION: Hypertension TRIAL DESIGN: International, multicenter, randomized, double-blind, active controlled, parallel-group. OBJECTIVES: To investigate the efficacy and safety of GMRx2 compared to dual combinations INTERVENTION: Single-Blind Active Run-In Period. Enrolled participants will be asked to discontinue their current BP-lowering drug(s) and undergo a single-blind active run-in period for 4 weeks with GMRx2 dose version 2. Participants will be advised to take the capsule once daily in the morning at approximately the same time each day. For days on which BP is being measured, the capsule should be taken directly after the morning home BP measurement. Double-Blind Treatment Period. Participants still eligible after the run-in period will be allocated in a double-blind fashion to one of the following 4 randomized groups: GMRx2 dose version 2, or telmisartan 20mg+amlodipine2.5mg, or telmisartan 20mg+indapamide 1.25mg, or amlodipine 2.5mg+indapamide 1.25mg. At week 6 all doses will be doubled.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg	Single pill
DRUG	telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg	Single pill
DRUG	Telmisartan 20 mg/amlodipine 2.5 mg	oral tablet
DRUG	telmisartan 40 mg/amlodipine 5 mg	oral tablet
DRUG	Telmisartan 20 mg/indapamide 1.25 mg	oral tablet
DRUG	telmisartan 40 mg/indapamide 2.5 mg	oral tablet
DRUG	Amlodipine 2.5 mg/indapamide 1.25 mg	oral tablet
DRUG	amlodipine 5 mg/indapamide 2.5 mg	oral tablet

Timeline

• Start date: 2021-07-09
• Primary completion: 2023-08-11
• Completion: 2023-09-01
• First posted: 2020-08-19
• Last updated: 2025-06-03
• Results posted: 2025-06-03

Locations

89 sites across 7 countries: United States, Australia, Czechia, New Zealand, Poland, Sri Lanka, United Kingdom

Regulatory

• FDA-regulated drug study