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
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.
Summary of results: What is the study background and why was the study done?
Blood pressure is the force of your blood pushing against blood vessels, when your heart beats. Blood vessels are the channels that carry blood throughout your body. A blood pressure measurement is given as two numbers
• The top number (systolic) shows the pressure when your heart beats.
• The bottom number (diastolic) shows the pressure when your heart rests between beats.A normal blood pressure measurement in adults is ideally <120/80mm Hg.
High blood pressure puts a strain on your heart and blood vessels. It increases the risk of heart attack and stroke, so many people take medication to help control it. In the past, doctors usually started treatment of high blood pressure with one medication that lowered blood pressure. more current research shows that starting treatment with a mix of up to three blood pressure medications at a low dose right from the beginning may work better.
This study looked at a new single-pill treatment for high blood pressure called GMRx2. The pill combines small doses of three existing blood pressure medicines—telmisartan, amlodipine, and indapamide—into one tablet. Researchers tested two different doses of GMRx2 and compared them to a placebo (a fake pill with no medicine) to see how well GMRx2 lowered blood pressure and whether it was safe to use.
What did the study involve?
Participants from the following five countries took part in the study:
Australia, Nigeria, Sri Lanka, the UK, and the USAWho Was Involved?
• 295 adults with high blood pressure joined the study.
• Men and women were included, and most were around 51 years old.
• Everyone had to be over 18 years old.
• They were either not taking any medicine or only one type of blood pressure medicine.What Did They Do?
Before starting the trial, everyone stopped their usual medicine for two weeks and took a fake pill (placebo). This helped the researchers see how their blood pressure changed without any medicine. In the UK, people were told the pill was a placebo before they took the pill. In other countries, they didn’t know.After the two weeks, the participants measured their blood pressure at home. If the top number (systolic) was between 130–154 mm Hg, they were put into one of three groups at random to keep things fair.
What Were the Groups?
• Group 1: 40% got a low dose of the new medicine (GMRx2 ¼ dose)
• Group 2: 40% got a medium dose (GMRx2 ½ dose)
• Group 3: 20% kept taking the placeboThis part of the study was double-blind, which means nobody - not the doctors or the patients — knew who was taking what dose or placebo. That way, people’s thoughts and guesses didn’t affect the results.
What Did They Measure?
Each person took their tablet every morning at home and measured their blood pressure. After four weeks, they went back to the clinic for a final check.What did the researchers find?
Those who took either a ¼ or ½ dose of the new treatment (GMRx2) had lower blood pressure readings compared to those who took the placebo.The most common side effects during the study were:
• Low blood pressure.
• Unusual blood test results.
• Headaches.
• Swelling in the legs, feet, or ankles.These side effects were more common in people taking GMRx2 ½ dose (Group 2), except for headaches, which were reported more often in the placebo group (Group 3).
Seven participants stopped taking the medication early because of side effects - six were taking the GMRx2 ½ (Group 2) and one was on the placebo (Group 3).
Four participants had serious health issues during the study. A serious health issue is any medical issue that results in hospitalization, is life-threatening, causes long-term problems, or even leads to death.
• Two in the GMRx2 ½ dose (Group 2) - one got COVID-19 and one had a non-fatal stroke.
• Two in the placebo (Group 3) - both got COVID-19.No one died during the study.
What does it mean?
The new single tablet treatment, GMRx2 containing low doses of three different blood pressure medication (telmisartan, amlodipine and indapamide,) in a single pill, was effective at lowering blood pressure and was well tolerated.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