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Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

Efficacy and Safety of GMRx2 (a Single Pill Combination Containing Telmisartan/Amlodipine/Indapamide) Compared to Dual Combinations for the Treatment of Hypertension

NCT04518293•George Medicines PTY Limited

View on ClinicalTrials.gov

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.

Detailed Description

TRIAL DRUG: GMRx2: Single pill combinations of telmisartan/amlodipine/indapamide Dose version 2: telmisartan 20mg/amlodipine 2.5mg/indapamide 1.25mg Dose version 3: telmisartan 40mg/amlodipine 5 mg/indapamide 2.5mg INDICATION: Hypertension TRIAL DESIGN: International, multicenter, randomized, double-blind, active controlled, parallel-group. OBJECTIVES: To investigate the efficacy and safety of GMRx2 compared to dual combinations INTERVENTION: Single-Blind Active Run-In Period. Enrolled participants will be asked to discontinue their current BP-lowering drug(s) and undergo a single-blind active run-in period for 4 weeks with GMRx2 dose version 2. Participants will be advised to take the capsule once daily in the morning at approximately the same time each day. For days on which BP is being measured, the capsule should be taken directly after the morning home BP measurement. Double-Blind Treatment Period. Participants still eligible after the run-in period will be allocated in a double-blind fashion to one of the following 4 randomized groups: GMRx2 dose version 2, or telmisartan 20mg+amlodipine2.5mg, or telmisartan 20mg+indapamide 1.25mg, or amlodipine 2.5mg+indapamide 1.25mg. At week 6 all doses will be doubled.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•At screening visit
•1. Provided signed consent to participate in the trial.
•2. Adult of age ≥18 years.
•3. Attended automated clinic seated mean systolic blood pressure (SBP) (average of last 2 measurements calculated by the device):
•140-179 mmHg on 0 BP-lowering drugs, or 130-170 mmHg on 1 BP-lowering drug, or 120-160 mmHg on 2 BP-lowering drugs, or 110-150 mmHg on 3 BP-lowering drugs.
•At randomization visit
•1. Home seated mean SBP 110-154 mmHg in the week prior to the randomization visit.
•2. Adherence of 80-120% to run-in medication.
•3. Tolerated run-in medication.
•4. Adherence to home BP monitoring schedule: in the week before randomization, at least 6 measures (e.g. ≥2 sets of triplicate measures, ≥3 sets of duplicate measures) including at least 1 morning and 1 evening each with ≥2 measures. Morning is defined as any measure in the am and evening as any measure in the pm. Morning and evening do not have to be same day.

Exclusion Criteria

•At screening visit
•1. Receiving 4 or more BP-lowering drugs.
•2. Receiving any BP lowering drugs for indications other than hypertension e.g. heart failure
•3. Pregnant or had a positive pregnancy test or unwilling to undertake a pregnancy test during the trial and up to 30 days after the discontinuation of the trial medication or breastfeeding or of childbearing age and not using an acceptable method of contraception. Acceptable methods of birth control include hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (e.g. condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization. Contraception should be used for at least 1 month before the screening visit and until the end of trial participation.
•4. Not suitable for participation in a clinical trial according to local ethical or regulatory requirements related to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).
•5. Contraindication, including hypersensitivity (e.g. anaphylaxis or angioedema), to the active run-in treatment or to any of the trial medication options in the four randomized groups.
•6. Current/history of transient ischemic attack, stroke, or hypertensive encephalopathy.
•7. Current/history of acute coronary syndrome, unstable angina, myocardial infarction, percutaneous transluminal coronary revascularization, or coronary artery bypass graft.
•9. Current/history of New York Heart Association class III and IV congestive heart failure.
•10. Current/history of a known secondary cause of hypertension, such as primary aldosteronism, renal artery stenosis, pheochromocytoma, or Cushing's syndrome.
+18 more criteria

Locations (89)

Elite Clinical Studies

Phoenix, Arizona, United States

Headlands Research

Scottsdale, Arizona, United States

Quality of Life Medical & Research Associates

Tucson, Arizona, United States

Valiance Clinical Research

South Gate, California, United States

Valiance Clinical Research

Tarzana, California, United States

Clinical Research of Brandon

Brandon, Florida, United States

Inpatient Research Clinic

Hialeah, Florida, United States

Multi-Speciality Research Associates

Lake City, Florida, United States

Suncoast Research Group

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Key Dates

Start Date

July 9, 2021

Primary Completion Date

August 11, 2023

Completion Date

September 1, 2023

Last Updated

June 3, 2025

Enrollment

1,385

ACTUAL participants

Conditions

Hypertension

Interventions

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

telmisartan 40 mg/indapamide 2.5 mg

DRUG

Amlodipine 2.5 mg/indapamide 1.25 mg

DRUG

amlodipine 5 mg/indapamide 2.5 mg

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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