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
- Conditions
- Hypertension
- Registration Number
- SLCTR/2023/009
- Lead Sponsor
- George Medicines Pty Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
At screening visit,
1. Adult aged >=18 years.
2. Male or female
3. Low calculated cardiovascular risk according to local guidelines such that pharmacological blood pressure (BP) lowering treatment is not mandatory: E.g. Pooled Cohorts Equation 10-years Atherosclerotic cardiovascular disease (ASCVD) risk <10% in the United States.
4. Likely diagnosis of hypertension, defined as:
- automated Systolic blood pressure (SBP) at this clinic visit of >= 130mmHg on no BP lowering medicines or >= 120mmHg on 1 BP lowering medicine that will be stopped at this visit, OR
- documentation in last 6 months of office SBP >=140 mmHg and/or Diastolic
blood pressure (DBP) > >= 90mmHg on no BP lowering medicines or SBP>=130 and/or DBP >=85mmHg on 1 BP lowering medicine that will be stopped at this visit, OR
- documentation in last 6 months of home SBP .+130 mmHg and/or DBP >=80mmHg on no BP lowering medicines or SBP >=120 mmHg and/or DBP >=75mmHg on 1 BP lowering medicine that will be stopped at this visit, OR
- documentation in last 6 months of ambulatory daytime SBP >=130 mmHg and/or DBP >=80mmHg on no BP lowering medicines or SBP >=120 mmHg and/or DBP >=75mmHg on 1 BP lowering medicine that will be stopped at this visit.
5. At randomization visit,
1. Home SBP 130-154 mmHg.
2. Adherence of 80-120% to run-in medication.
3. Tolerated run-in medication.
4. Adhered to home BP monitoring schedule.
At week 4 (for optional Open-Label Extension Period)
1. Completed randomized treatment and willing to continue GMRx2-based regimen for 12 months
At screening visit
1. Receiving 2 or more BP-lowering drugs.
2. Contraindication to placebo run-in or any of the trial medications.
At randomization visit
1. Contraindication to any of the randomized medications including placebo
At week 4 (for optional Open-Label Extension Period)
1. Contraindication to any of the open-label GMRx2-based BP-lowering treatment regimen.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in change in home seated mean SBP from randomization [Base line and Week 4 from starting intervention]<br>
- Secondary Outcome Measures
Name Time Method