Efficacy and Safety of GMRx2 Compared to Placebo for the Treatment of Hypertension
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT04518306
- Lead Sponsor
- George Medicines PTY Limited
- Brief 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 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 placebo.
- Detailed Description
TRIAL DRUG:
GMRx2: single pill combination of telmisartan/amlodipine/indapamide Dose version 1: telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Dose version 2: telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg I NDICATION: Hypertension
TRIAL TITLE:
Efficacy and safety of GMRx2 compared to placebo for the treatment of hypertension.
OBJECTIVES:
To investigate the efficacy and safety of GMRx2 compared to placebo for the treatment of hypertension.
INTERVENTION:
A 2-week single-blind placebo run-in will be followed by a 4-week double-blind period with randomization to GMRx2 dose version 1, GMRx2 dose version 2 or placebo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 295
Not provided
At screening visit:
- Receiving 2 or more BP-lowering drugs.
- Clinic seated mean SBP ≥160 mmHg and/or DBP ≥100 mmHg.
- 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.
- 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).
- Contraindication, including hypersensitivity (e.g. anaphylaxis or angioedema), to any of the 3 trial medications.
- Current/history of transient ischemic attack, stroke, or hypertensive encephalopathy.
- Current/history of acute coronary syndrome, unstable angina, myocardial infarction, percutaneous transluminal coronary revascularization, or coronary artery bypass graft.
- Current/history of New York Heart Association class III and IV congestive heart failure.
- Current/history of a known secondary cause of hypertension, such as primary aldosteronism, renal artery stenosis, pheochromocytoma, or Cushing's syndrome.
- Current/history of substantially uncontrolled diabetes (HbA1c > 11.0%) within last three months.
- Current/history of end-stage renal disease or anuria or estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2.
- Current/history of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the upper limit of normal range within 6 months.
- Current concomitant illness or physical impairment or mental condition that in the judgment of the investigator could interfere with the effective conduct of the trial or constitutes a significant risk to the participants' well-being.
- Arm circumference that is too large (>55 cm) or too small (<20 cm) to allow accurate measurement of BP.
- Currently taking or might need during the trial, a concomitant treatment which is known to interact significantly with the trial medication: digoxin, lithium, diabetics receiving aliskiren, moderate and strong CYP3A4 inhibitors [e.g. ritonavir, ketoconazole, diltiazem], simvastatin >20 mg/day, immunosuppressants.
- Might need treatment with drugs that are prohibited during the trial: other antihypertensive drugs, endothelin receptor antagonists, neprilysin inhibitors, or other drugs that may affect BP (see Error! Reference source not found.).
- Current surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of trial drugs such as prior major gastrointestinal tract surgery (e.g. gastrectomy, lap band, or bowel resection) or acute flare of inflammatory bowel disease within one year.
- Individuals working >2-night shifts per week.
- Participated in any investigational drug or device trial within the previous 30 days.
- History of alcohol or drug abuse within 12 months.
At randomization visit:
-
Unable to adhere to the trial procedures during the run-in period.
-
Any of the following which in the investigator's judgment may compromise the safety of the participant if randomized to the trial medications:
- High or low clinic BP levels even in the light of the values for home BP that are available for that participant. The exact levels of BP are not specified, since there is clinical uncertainty as to the relevance of BP levels which are high/low in clinic only; for example the clinical relevance of 'whitecoat hypertension' is uncertain.
- High or low home DBP levels. The exact levels of DBP are not specified, reflecting clinical uncertainty of for example isolated diastolic hypertension. However, home DBP values of >99 mmHg may typically be considered as requiring treatment intensification, and such participants would not be suitable for randomization.
-
Any abnormal laboratory value which in the judgment of the investigator could interfere with the effective conduct of the trial or constitutes a significant risk to the participants' well-being.
-
Fulfilling any of the exclusion criteria mentioned for the screening visit, when verified again at randomization visit.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Triple ½ (GMRx2) Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Triple ¼ (GMRx2) Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Difference in change in home seated SBP from baseline to Week 4 4 weeks
- Secondary Outcome Measures
Name Time Method Difference in change in trough home seated mean DBP from baseline to week 4 4 weeks Difference in change in clinic seated mean DBP from baseline to Week 4 4 weeks Percentage of participants with clinic seated mean SBP <140 and DBP <90 mmHg at Week 4 4 weeks Percentage of participants with home seated mean SBP <135 and DBP <85 mmHg at Week 4 4 weeks Percentage of participants with clinic seated mean SBP <130 and DBP <80 mmHg at Week 4 4 weeks Difference in change in clinic seated mean SBP from baseline to Week 4 4 weeks Percentage of participants with home seated mean SBP <130 and DBP <80 mmHg at Week 4 4 weeks Difference in change in home seated mean DBP from baseline to Week 4 4 weeks Difference in change in trough home seated mean SBP from baseline to week 4 4 weeks
Trial Locations
- Locations (43)
Buckhead Primary Care Research
🇺🇸Snellville, Georgia, United States
Valiance Clinical Research
🇺🇸Tarzana, California, United States
Albany House Medical Centre
🇬🇧Wellingborough, United Kingdom
North Hills Medical Research
🇺🇸North Richland Hills, Texas, United States
Ocala Research Institute
🇺🇸Ocala, Florida, United States
Synergy Groups Medical
🇺🇸Missouri City, Texas, United States
Castle Hill Medical Centre
🇦🇺Castle Hill, New South Wales, Australia
Clinical Research of Brandon
🇺🇸Brandon, Florida, United States
Kurunegala Teaching Hospital
🇱🇰Kurunegala, Sri Lanka
Suncoast Research Associates
🇺🇸Saint Petersburg, Florida, United States
Newquay Medical
🇬🇧Newquay, Cornwall, United Kingdom
Belmont Health Centre
🇬🇧Harrow, London, United Kingdom
Lakeside Surgery
🇬🇧Coventry, West Midlands, United Kingdom
Altus Research, Inc
🇺🇸Palm Beach, Florida, United States
Accel Research
🇺🇸Saint Petersburg, Florida, United States
Precision Clinical Research
🇺🇸Sunrise, Florida, United States
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Karapitiya Teaching Hospital
🇱🇰Galle, Sri Lanka
Kandy National Hospital
🇱🇰Kandy, Sri Lanka
Abbeywell Surgery
🇬🇧Romsey, United Kingdom
Curtin University
🇦🇺Bentley, Western Australia, Australia
Colombo North Teaching Hospital
🇱🇰Ragama, Sri Lanka
Burbage Surgery
🇬🇧Hinckley, Leicestershire, United Kingdom
Headlands Research
🇺🇸Scottsdale, Arizona, United States
West Walk Surgery
🇬🇧Bristol, Somerset, United Kingdom
Quality of Life Medical & Research Centers, LLC
🇺🇸Tucson, Arizona, United States
The University of Tennessee Health Science Center
🇺🇸Memphis, Tennessee, United States
Steploe Medical Centre
🇬🇧Soham, Cambridgeshire, United Kingdom
Aminu Kano Teaching Hospital
🇳🇬Kano, Nigeria
Institute of Cardiology, National Hospital of Sri Lanka
🇱🇰Colombo, Sri Lanka
Colombo South Teaching Hospital
🇱🇰Dehiwala, Sri Lanka
Barwon Health, Geelong University Hospital
🇦🇺Geelong, Victoria, Australia
University of Abuja Teaching Hospital
🇳🇬Gwagwalada, Federal Capital Territory, Nigeria
Jafna Teaching Hospital
🇱🇰Jaffna, Sri Lanka
Brockwood Medical Practice
🇬🇧Betchworth, Surrey, United Kingdom
Trowbridge Health Centre
🇬🇧Trowbridge, Wiltshire, United Kingdom
Hudson Institute of Medical Research
🇦🇺Clayton, Victoria, Australia
Elite Clinical Studies
🇺🇸Phoenix, Arizona, United States
Inpatient Research Clinic
🇺🇸Hialeah, Florida, United States
Suncoast Research Group
🇺🇸Miami, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Precision Research Center
🇺🇸Tampa, Florida, United States
Meridian Clinical Research
🇺🇸Portsmouth, Virginia, United States