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NCT04518306 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of GMRx2 Compared to Placebo for the Treatment of Hypertension
A Phase 3 study, sponsored by George Medicines PTY Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 755
- Enrollment target
NCT04518306: Completed Phase 3 study, sponsored by George Medicines PTY Limited.
NCT04518306 is a Phase 3 study that has completed, run by George Medicines PTY Limited. The registered enrollment target is 755 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04518306, a Phase 3 study, has completed, sponsored by George Medicines PTY Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 755 participants
- Enrollment target
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 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 placebo.
Primary Outcome
Each blood pressure (BP) measurement consisted of valid SBP values (ie. SBP\>60 mmHg and \<250 mmHg). BP values were summarized using descriptive statistics, including actual values and changes from randomization to Week 4, by timepoint and treatment groups.
Interventions
- DRUG Placebo
- DRUG Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg
- DRUG Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 755 participants |
| Start Date | 2021-06-14 |
| Est. Completion | 2023-10-18 |
| Phase | Phase 3 |
What the finished NCT04518306 record still lists
NCT04518306 is an interventional study that assigns participants to a tested intervention. The registered 755 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04518306 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04518306 about?
NCT04518306 is a clinical study titled "Efficacy and Safety of GMRx2 Compared to Placebo 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 control without increasing adverse effects. This trial is designed to i...
What is the current status of trial NCT04518306?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 755 participants. The study started on 2021-06-14. Estimated completion is 2023-10-18.
What interventions are being tested in trial NCT04518306?
The interventions under investigation include: Placebo (DRUG), Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg (DRUG), Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg (DRUG).
Who is sponsoring clinical trial NCT04518306?
This trial is sponsored by George Medicines PTY Limited, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04518306's enrollment target sits among peer trials
755 459th of 2000 higher than 1,541 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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