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Efficacy and Safety of GMRx2 Compared to Placebo for the Treatment of Hypertension (GMRx2_PCT 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 days
Treatment 3 months
Follow Up 1 month
Awards & highlights
Pivotal Trial
Summary
This trial tests GMRx2, a combination pill for high blood pressure, on people with hypertension. It aims to see if GMRx2 is more effective and safer. The pill works by relaxing blood vessels, reducing body fluid, and improving heart function.
Eligible Conditions
- High Blood Pressure
Timeline
Screening ~ 3 days1 visit
Treatment ~ 3 months6 visits
Follow Up ~ 1 month1 visit
Screening ~ 3 days
Treatment ~ 3 months
Follow Up ~1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Other study objectives
Primary Safety Outcome
Secondary Safety Outcome 1
Secondary Safety Outcome 10
+8 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Triple ¼ (GMRx2)Experimental Treatment1 Intervention
Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg
Group II: Triple ½ (GMRx2)Active Control1 Intervention
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg
Group III: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg
2021
Completed Phase 3
~300
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Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
George Medicines PTY LimitedLead Sponsor
2 Previous Clinical Trials
1,385 Total Patients Enrolled
Anthony Rodgers, ProfessorPrincipal InvestigatorThe George Institute
1 Previous Clinical Trials
1,385 Total Patients Enrolled