Health Condition 1: null- patients with persistent hypertension for at least 6 weeks despite adequate lifestyle advice and/or lifestyle changes
Conditions
Interventions
Intervention1: Triple Pill: Triple Pill: strength 1 - Telmisartan 20mg, Amlodipine 2.5mg, Chlorthalidone 12.5mg
one tablet/once daily/6 months/oral
OR
strength 2 - Telmisartan 40mg, Amlodipine 5mg, Chlorthalidone 25mg
one tablet/once daily/6 months/oral
Control Intervention1: Usual Care: Usual BP management
Sponsors
The George Institute For Global Health Australia
The George Institute of Global Health India
Eligibility
Inclusion criteria
Inclusion criteria: Adults >=18 years of age. Sustained ( > 6 weeks) SBP > 140 mmHg and/or DBP > 90 mmHg (or SBP > 130 mmHg and/or DBP > 90 mmHg in patients with Diabetes or Chronic Kidney Disease) despite diet and lifestyle advice and/or the use of single drug therapy. Trial Investigator is unsure as to whether a Triple Pill based therapy or usual care is better.
Exclusion criteria
Exclusion criteria: On two or more BP lowering drugs Severe or uncontrolled BP (SBP 180 mmHg and/or DBP 110 mmHg) Accelerated hypertension or hypertension at a level where the physician feels that slower up-titration of treatment is appropriate (e.g. elderly patients) Contraindication to any of the components of the Triple Pill Pregnancy, breast feeding, childbearing potential not on effective medically accepted method of child birth control. Unstable medical condition or known situation where medication regimen might be altered for a significant length of time, e.g. current acute cardiovascular event, planned coronary bypass graft operation, dialysis. Participants with clinically significant abnormal laboratory value judged to be unsuitable for trial participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving target BP at the end of 6 months follow up: SBP 140 mmHg and DBP 90 mmHg (SBP 130 mmHg and DBP 85 mmHg for patients with Diabetes and Chronic Kidney Disease)Timepoint: at 6 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in SBP and DBPTimepoint: at 6 months;Proportion of participants with BP control Timepoint: at 6 weeks and 12 weeks;Quality of lifeTimepoint: at 6 months;Self-reported BP lowering medication use (7-day recall)Timepoint: at 6 months;Tolerance to treatmentTimepoint: at 6 months;Use of health care services (hospitalizations, medical consultations, tests)Timepoint: at 6, 12 weeks and 6 months | — |
Countries
India
Contacts
Public ContactDr Anushka Patel
George Institute For Global Health
Outcome results
None listed