GMRx2_PCT1
Research type
Research Study
Full title
Efficacy and safety of GMRx2 (a single pill combination containing telmisartan/amlodipine/indapamide) compared to placebo for the treatment of hypertension: An international, multi-center, randomized, double-blind, placebo-controlled, parallel-group trial.
IRAS ID
1005168
Contact name
Karl Roberts
Contact email
Sponsor organisation
George Medicines Pty Limited
Eudract number
2022-000640-29
Clinicaltrials.gov Identifier
Research summary
High blood pressure is a cause of cardiovascular (CV) disease which includes heart attack and stroke. Therefore, managing high blood pressure is important in the prevention of CV disease. Most people with high blood pressure do not achieve adequate blood pressure control with just one medication.\nThis trial is evaluating a new medicine called GMRx2, which is a single pill combination containing active ingredients from three different blood pressure-lowering medications called telmisartan, amlodipine and indapamide. All three of these medications have been given to large numbers of people over the last few decades and are already prescribed in many countries. These medications have been used either on their own or in combination with other blood pressure-lowering medications.\nThe purpose of this trial is to find out if the GMRx2 triple combination medication is effective and safe in lowering high blood pressure compared to placebo (‘dummy’ treatment). \nThe trial is sponsored and funded by George Medicines. The study design is a multicentre, randomised, double-blind, placebo-controlled, parallel-group study, taking place in USA, Australia and the UK across primary and secondary care sites. A total of 250 adults with low cardiovascular risk scores who can be appropriately treated with trial medication will be enrolled globally. The trial has a run-in period (2 weeks), treatment phase (4 weeks), and a safety follow-up period (4 weeks). More participants will be allocated to receive GMRx2 active treatment than placebo. Participants will be expected to take the trial medication daily and regularly monitor their blood pressure at home between their clinic visits (minimum of 3 visits).\nAn optional 12-month open-label extension may be offered to patients at the end of the study; however, the Sponsor is yet to decide which countries will be involved.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0450
Date of REC Opinion
2 Feb 2023
REC opinion
Further Information Favourable Opinion