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Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg for High Blood Pressure (GMRx2_PCT Trial)

Phase 3
Recruiting
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 months
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 days
Treatment ~ 3 months
Follow Up ~1 months
This trial's timeline: 3 days for screening, 3 months for treatment, and 1 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in change in home SBP from baseline to Week 4
Secondary study objectives
Difference in change in clinic seated mean DBP from baseline to Week 4
Difference in change in clinic seated mean SBP from baseline to Week 4
Difference in change in home seated mean DBP from baseline to Week 4
+6 more
Other study objectives
Safety Outcomes

Awards & 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

Find a Location

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
~57 spots leftby Nov 2025
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