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NCT04518293 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension
A Phase 3 study of Hypertension, sponsored by George Medicines PTY Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,385
- Enrollment target
- 20
- Study locations
NCT04518293: Completed Phase 3 study of Hypertension, sponsored by George Medicines PTY Limited.
NCT04518293 is a Phase 3 study of Hypertension that has completed, run by George Medicines PTY Limited. The registered enrollment target is 1,385 participants, below the 3,504-participant average among 470 other Hypertension trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04518293, a Phase 3 study of Hypertension, has completed, sponsored by George Medicines PTY Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,385 participants
- Enrollment target
- 20
- Study locations
Study Summary
Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients. Several trials suggest triple low-dose combination therapy may be highly effective in terms of achieving blood pressure (BP) control without increasing adverse effects. This trial is designed to investigate the efficacy and safety of GMRx2 in participants with high blood pressure compared to dual combinations.
Primary Outcome
The primary outcome measure is difference in change in average home SBP for GMRx2 vs each dual combination evaluated from randomization to Week 12. The change in home SBP from randomization for all treatment arms was measured using least squares (LS) mean change. The pairwise comparisons between GMRx2 and dual treatments in change in home SBP were estimated using LS means difference and are described in the statistical analysis.
Conditions Studied
Interventions
- DRUG Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg
- DRUG telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
- DRUG Telmisartan 20 mg/amlodipine 2.5 mg
- DRUG telmisartan 40 mg/amlodipine 5 mg
- DRUG Telmisartan 20 mg/indapamide 1.25 mg
Study Locations (20)
Florida
- Clinical Research of Brandon - Brandon
- Inpatient Research Clinic - Hialeah
- Multi-Speciality Research Associates - Lake City
- Suncoast Research Group - Miami
- New Horizon Research Center - Miami
- Ocala Research Institute - Ocala
- Suncoast Research Associates - St. Petersburg
- Accel Research - St. Petersburg
- Precision Research Center - Tampa
Arizona
- Elite Clinical Studies - Phoenix
- Headlands Research - Scottsdale
- Quality of Life Medical & Research Associates - Tucson
California
- Valiance Clinical Research - South Gate
- Valiance Clinical Research - Tarzana
Georgia
- Meridian Clinical Research - Savannah
- Buckhead Primary Care Research - Snellville
Illinois
- Loyola University - Maywood
Louisiana
- Meridian Clinical Research - Baton Rouge
New York
- Meridian Clinical Research - Endwell
North Carolina
- Javarra Research - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,385 participants |
| Start Date | 2021-07-09 |
| Est. Completion | 2023-09-01 |
| Phase | Phase 3 |
What the finished NCT04518293 record still lists
NCT04518293 is an interventional study that assigns participants to a tested intervention. Its 1,385 participants enrollment target places it among the larger protocols in the corpus, below the 3,504-participant average among 470 other Hypertension trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 5 interventions - of which Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg is the first listed.
NCT04518293 names 20 study sites across 8 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04518293 about?
NCT04518293 is a clinical study titled "Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension". Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients. Several trials suggest triple low-dose combination therapy may be highly effective in terms of achieving blood pressure (BP) control without increasing adverse effects. This trial is designed...
What is the current status of trial NCT04518293?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,385 participants. The study started on 2021-07-09. Estimated completion is 2023-09-01.
What conditions does trial NCT04518293 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT04518293?
The interventions under investigation include: Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg (DRUG), telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg (DRUG), Telmisartan 20 mg/amlodipine 2.5 mg (DRUG), telmisartan 40 mg/amlodipine 5 mg (DRUG), Telmisartan 20 mg/indapamide 1.25 mg (DRUG).
Who is sponsoring clinical trial NCT04518293?
This trial is sponsored by George Medicines PTY Limited, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04518293 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04518293's enrollment target sits among peer trials
1,385 47th of 470 higher than 424 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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