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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
Funding organisation
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%.
Current status
Ethics: 16/20 site EC approvals in India + Sydney. Submitted for approval in Sri Lanka.
EC
approval: Health Ministry Screening Committee (HMSC): queries
answered to
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 - rwebster@georgeinstitute.org.au
Investigators
- 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
Publications
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