GMRx2_HTN_2020_ACT1
Research type
Research Study
Full title
Efficacy and safety of GMRx2 (a single pill combination containing telmisartan/amlodipine/indapamide) compared to dual combinations for the treatment of hypertension: An international, multi-center, randomized, double-blind, activecontrolled, parallel-group trial
IRAS ID
1004214
Contact name
Karl Roberts
Contact email
Sponsor organisation
George Medicines Pty Limited
Eudract number
2020-004196-40
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.
This 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.
The purpose of this trial is to find out if the GMRx2 triple combination medication is equally or more effective and as safe in lowering high blood pressure compared with any combination of 2 of the active ingredients and which will form the basis on a marketing registration application to the US FDA.
The Sponsor is George Medicines. The study design is a multicenter, randomized, double-blind, active-controlled, parallel-group study, taking place in several countries including USA, Australia, New Zealand, Sri Lanka, Poland, Czech Republic, South Korea and UK. The trial has a single-blind run-in period (4 weeks), two double-blind treatment periods (6 weeks each), and a safety follow-up period (4 weeks). An optional 12 month open-label extension (OLE) may be offered to patients at Week 12; however, the Sponsor is yet to decide which countries will be involved. If UK is chosen, a substantial amendment will be submitted.
The results of this trial will help doctors to learn more about this blood pressure-lowering medication, hypertension and how to treat it. This may help others with high blood pressure in the future.REC name
South Central - Oxford B Research Ethics Committee
REC reference
21/SC/0373
Date of REC Opinion
21 Dec 2021
REC opinion
Further Information Favourable Opinion