Hypertension
Conditions
Interventions
Study sites
National Hospital of Sri Lanka,
Kandy Teaching Hospital,
Colombo North Teaching Hospital,
Colombo South Teaching Hospital,
Teaching Hospital Kurunegala,
Jaffna Teaching Hospital,
Karapiti
Sponsors
George Medicines Pty Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 = 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in change in home seated mean SBP from randomization [Base line and Week 4 from starting intervention] | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in change in clinic seated mean SBP from baseline to Week 4 [Base line and Week 4 from starting intervention] Percentage of participants with clinic seated mean SBP <140 and DBP <90 mmHg at Week 4 [Base line and Week 4 from starting intervention] Percentage of participants with clinic seated mean SBP <130 and DBP <80 mmHg at Week 4 [Base line and Week 4 from starting intervention] Difference in change in home seated mean DBP from baseline to Week 4 [ Base line and Week 4 from starting intervention] Difference in change in trough home seated mean SBP from baseline to week 4 [Base line and Week 4 from starting intervention] Difference in change in trough home seated mean DBP from baseline to week 4 [ Base line and Week 4 from starting intervention] Percentage of participants with home seated mean SBP <135 and DBP <85 mmHg at Week 4 [ Base line and Week 4 from starting intervention] Percentage of participants with home seated mean SBP <130 and DBP <80 mmHg at Week 4 [ Base line and Week 4 from starting intervention] Difference in change in clinic seated mean DBP from baseline to Week 4 [ Base line and Week 4 from starting intervention ] Percentage of participants with clinic seated mean SBP <140 and DBP <90 mmHg at Week 4 [ Base line and Week 4 from starting intervention] Percentage of participants with clinic seated mean SBP <130 and DBP <80 mmHg at Week 4 [ Base line and Week 4 from starting intervention] Difference in change in home seated mean DBP from baseline to Week 4 [ Base line and Week 4 from starting intervention] Difference in change in trough home seated mean SBP from baseline to week 4 [ Base line and Week 4 from starting intervention] Difference in change in trough home seated mean DBP from baseline to week 4 [ Base line and Week 4 from starting intervention] Percentage of participants with home seated mean SBP <135 and DBP <85 mmHg at Week 4 [ Base line and Week 4 from starting intervention ] Percentage of participants with ho | — |
Countries
Australia,Nigeria,Sri Lanka,United Kingdom,United States
Contacts
Public ContactDr. Gotabhaya Ranasinghe
General and Interventional Cardiologist
Outcome results
None listed