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Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension

NCT04518293 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1385

Last updated 2025-06-03

Study results available
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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

Interventions

DRUG

Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg

Single pill

DRUG

telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg

Single pill

DRUG

Telmisartan 20 mg/amlodipine 2.5 mg

oral tablet

DRUG

telmisartan 40 mg/amlodipine 5 mg

oral tablet

DRUG

Telmisartan 20 mg/indapamide 1.25 mg

oral tablet

DRUG

telmisartan 40 mg/indapamide 2.5 mg

oral tablet

DRUG

Amlodipine 2.5 mg/indapamide 1.25 mg

oral tablet

DRUG

amlodipine 5 mg/indapamide 2.5 mg

oral tablet

Sponsors & Collaborators

  • George Medicines PTY Limited

    lead INDUSTRY

Principal Investigators

  • Anthony Rodgers, Professor · The George Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-09
Primary Completion
2023-08-11
Completion
2023-09-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Czechia
  • New Zealand
  • Poland
  • Sri Lanka
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04518293 on ClinicalTrials.gov