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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

HT08 project video

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

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