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Calcium Channel Blocker/Thiazide Diuretic Combination

Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg for High Blood Pressure(GMRx2_ACT 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
Attended automated clinic seated mean SBP (average of last 2 measurements calculated by the device):
150-179 mmHg on 0 blood pressure (BP)-lowering drugs, or 140-170 mmHg on 1 BP-lowering drug, or 130-160 mmHg on 2 BP-lowering drugs, or 120-150 mmHg on 3 BP-lowering drugs
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up12 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

GMRx2_ACT Trial Summary

This trial is investigating whether a triple low-dose combination therapy is more effective and has fewer side effects than dual combinations when treating high blood pressure.

GMRx2_ACT Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

GMRx2_ACT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in change in home SBP from baseline to week 12
Secondary outcome measures
Difference in change in clinic seated mean DBP from baseline to Week 12
Difference in change in clinic seated mean DBP from baseline to Week 6
Difference in change in clinic seated mean SBP from baseline to Week 12
+14 more
Other outcome measures
Safety Outcomes

Awards & Highlights

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

GMRx2_ACT 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

Find a Location

Who is running the clinical trial?

George Medicines PTY LimitedLead Sponsor
2 Previous Clinical Trials
584 Total Patients Enrolled
Anthony Rodgers, ProfessorPrincipal InvestigatorThe George Institute
1 Previous Clinical Trials
250 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions does Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg help ameliorate?

"Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg can help patients who have cardiovascular issues, are at high risk for cardiovascular problems, or have dyslipidemias."

Answered by AI

Are there other research papers that explore the effects of taking Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg?

"The first study of Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg was completed in 2012 at UT Southwestern Medical Center. As of now, 473 studies have been completed in total. Out of the 40 active clinical trials, a large number are based out of North Richland Hills, Texas."

Answered by AI

In how many places is this particular clinical trial being conducted?

"There are 33 total sites for this ongoing clinical trial, including North Hills Medical Research (North Richland Hills, Texas), Suncoast Research Group (Miami, Virginia), and Meridian Clinical Research (Portsmouth, North Carolina, Virginls, Texas), Suncoast Research Group (Miami, Virginia), and Meridian Clinical Research (Portsmouth, North Carolina)."

Answered by AI

Has the FDA cleared Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg for public use?

"Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg is in Phase 3 of clinical trials, so there is some data to support its efficacy and multiple rounds of data that suggest it is safe. Therefore, our team at Power has given it a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Georgia
Other
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0
What site did they apply to?
Valiance Clinical Research
Inpatient Research Clinic
Buckhead Primary Care Research
Other

What questions have other patients asked about this trial?

How often are the visits? Do you get some type of payment ? Do you provide transportation for this trial?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

My bp is dangerously high. Because I want to be part of the solution. Been on Blood Pressure Medicine for many years.
PatientReceived 1 prior treatment
They want to increase the medication I am taking. I have high blood pressure and I want to help others with the same things.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension
2021. "Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04518293.
All > High Blood Pressure
~439 spots leftby Nov 2024
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