Hypertension HT08, 2012 – 2017

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

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.

Investigators

Publications

Funding organisations

  • Hypertension HT08
  • India, Sri Lanka
  • 2012 – 2017

Programme contact
Ruth Webster
rwebster@georgeinstitute.org.au