Hypertension Research Programme - HT08
Randomised control trial of early use of a simplified treatment regimen incorporating a half -dose, three-in-one blood pressure lowering pill vs. usual care for improving hypertension control in India
Project location: India, Sri Lanka
Project duration: 2012 - 2017
Primary research aim
To investigate effectiveness, cost-effectiveness, and acceptability of Triple pill (Triple BP lowering therapy) compared to usual care for early management of high BP in India and Sri Lanka.
Research objectives and methodology
Design: Randomised Controlled Trial, Economic Evaluation, and Process Evaluation.
Participants: Adults with high BP despite diet and lifestyle advice or single drug therapy.
Intervention: Triple pill vs. usual care.
Outcome: Proportion of participant achieving target BP at 6 months follow-up.
Sample: n=700, power = 90%, 2α = 0.05, 12% improvement in control rates from 50%.
Ethics: 16/20 site EC approvals in India + Sydney. Submitted for approval in Sri Lanka.
approval: Health Ministry Screening Committee (HMSC): queries
satisfaction. Drug Controller General of
India (DCGI): Major query answered, awaiting clearance. Awaiting
clearance from Faculty of Medicine Ethics Committee, University of
Kelaniya, Colombo, Sri Lanka.
Project contact: Ruth Webster - firstname.lastname@example.org
- Anushka Patel, The George Institute for Global Health, Sydney, Australia
- Anthony Rodgers, The George Institute for Global Health, Sydney, Australia
- Stephen Jan, The George Institute for Global Health, Sydney, Australia
- Ruth Webster, The George Institute for Global Health, Sydney, Australia
- Pallab Maulik, The George Institute for Gobal Health - India, New Delhi, India
- Abdul Salam, The George Institute for Gobal Health - India, New Delhi, India
- Dorairaj Prabhakaran, Centre for Chronic Disease Control, Gurgaon, India
- Simon Thom, Imperial College London, UK
Salam A, Webster R, Singh K, Kallakuri S, Rodgers A, Prabhakaran D, et al. TRIple pill vs Usual care Management for Patients with mild-to-moderate Hypertension (TRIUMPH): Study protocol. American heart journal. 2014; 167(2): 127-32