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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.

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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.

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

FieldValue
Enrollment Target 1,385 participants
Start Date 2021-07-09
Est. Completion 2023-09-01
Phase Phase 3

Sponsor

George Medicines PTY Limited

2 total trials

What the Registry Record Tells You About NCT04518293

The ClinicalTrials.gov registry entry for NCT04518293 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,385 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,504-participant average among 470 other Hypertension trials with a reported enrollment target (60% lower). The listed sponsor is George Medicines PTY Limited, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.