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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 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.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 moreOther 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
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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
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