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 INDICATION: 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
- 755
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 Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 Randomization to Week 4 Each blood pressure (BP) measurement consisted of valid SBP values (ie. SBP\>60 mmHg and \<250 mmHg). BP values were summarized using descriptive statistics, including actual values and changes from randomization to Week 4, by timepoint and treatment groups.
- Secondary Outcome Measures
Name Time Method Difference in Change in Clinic Seated Mean Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 Randomization to Week 4 Each blood pressure (BP) measurement consisted of valid SBP values (ie. SBP\>60 mmHg and \<250 mmHg). BP values were summarized using descriptive statistics, including actual values and changes from randomization to Week 4, by timepoint and treatment groups.
Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 Randomization to Week 4 Each blood pressure (BP) measurement consisted of valid DBP values (ie. DBP\>40mmHg and \<150mmHg). BP values were summarized using descriptive statistics, including actual values and changes from randomization to Week 4, by timepoint and treatment groups.
Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and DBP <90 mmHg at Week 4 At Week 4 The percentage of participants achieving averaged clinic SBP \<140 and DBP \<90 mmHg at Week 4 was evaluated.
Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 4 At Week 4 The percentage of participants achieving averaged clinic SBP \<130 and DBP \<80 mmHg at Week 4 was evaluated. Participants were analyzed in the treatment group to which they have been randomized.
Difference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 Randomization to Week 4 Each blood pressure (BP) measurement consisted of valid DBP values (ie. DBP\>40mmHg and \<150mmHg). BP values were summarized using descriptive statistics, including actual values and changes from randomization to Week 4, by timepoint and treatment groups. To evaluate the difference in change, least squares mean change value is reported.
Difference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 Randomization to Week 4 Difference in change in trough home SBP for GMRx2 vs placebo was evaluated at Week 4. Trough values were measured before morning dose of the study medication.
Difference in Change in Trough Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 Randomization to Week 4 Difference in change in trough home DBP for GMRx2 vs placebo was evaluated at Week 4. Trough values were measured before morning dose of the study medication. To evaluate the difference in change, least squares mean change value is reported.
Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 4 At Week 4 The percentage of participants achieving home seated mean SBP \<135 and DBP \<85 mmHg at Week 4 was evaluated
Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 4 Randomization to Week 4 The percentage of participants achieving averaged home seated mean SBP \<130 and DBP \<80 mmHg at Week 4 was evaluated
Trial Locations
- Locations (43)
Elite Clinical Studies
🇺🇸Phoenix, Arizona, United States
Headlands Research
🇺🇸Scottsdale, Arizona, United States
Quality of Life Medical & Research Centers, LLC
🇺🇸Tucson, Arizona, United States
Valiance Clinical Research
🇺🇸Tarzana, California, United States
Clinical Research of Brandon
🇺🇸Brandon, Florida, United States
Inpatient Research Clinic
🇺🇸Hialeah, Florida, United States
Suncoast Research Group
🇺🇸Miami, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Ocala Research Institute
🇺🇸Ocala, Florida, United States
Altus Research, Inc
🇺🇸Palm Beach, Florida, United States
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