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Calcium Channel Blocker/Thiazide Diuretic Combination

Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension (GMRx2_ACT Trial)

Phase 3
Waitlist Available
Led By Anthony Rodgers, Professor
Research Sponsored by George Medicines PTY Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial tests a combination pill called GMRx2 for people with high blood pressure. The pill combines three medications to relax blood vessels and reduce water and salt in the body. The goal is to see if it controls blood pressure better than other treatments.

Eligible Conditions
  • High Blood Pressure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Other study objectives
Percentage of participants discontinued trial medication due to AE/SAE from baseline to Week 6
Percentage of participants discontinued trial medication due to AE/SAE from baseline to week 12
Percentage of participants with SAE from baseline to Week 6
+13 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Triple - TAIExperimental Treatment2 Interventions
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Group II: Dual - TIActive Control2 Interventions
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Group III: Dual - AIActive Control2 Interventions
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Group IV: Dual - TAActive Control2 Interventions
Telmisartan 20 mg/amlodipine 2.5 mg . At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg
2021
Completed Phase 3
~1680
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
2021
Completed Phase 3
~1390

Find a Location

Who is running the clinical trial?

George Medicines PTY LimitedLead Sponsor
2 Previous Clinical Trials
295 Total Patients Enrolled
Anthony Rodgers, ProfessorPrincipal InvestigatorThe George Institute
1 Previous Clinical Trials
295 Total Patients Enrolled
~314 spots leftby Dec 2025
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