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Research

Photo for TIPS

TIPS

Official Title

The Indian Polycap Study

Status

Completed

Overview

To assess the efficacy and safety of the POLYCAP®, a fixed dose combination containing 5 drugs (an antiplatelet drug; 3 blood pressure lowering agents, a beta blocker, an ACE inhibitor, a diuretic and a statin. It is the first completed trial of polypill and tets primarily th efeasibility and pharmacological effects of various polypill preparations.

Study Design

Randomized, double-blind, active control, parallel group design, safety/efficacy study.

Primary Endpoint

The primary endpoints are Reduction in blood Pressure, Reduction in Heart Rate, Modify lipids. Secondary endpoints: Platelet aggregation. Not adjudicated

Number of Patients

2050

Number of Sites

70

Number of Countries

1

Study Period

2007–2009

Principal Investigator

Salim Yusuf

Program Manager

Jackie Bosch

Key Publications

  • Xavier D, Pais P, Sigamani A, Pogue J, Afzal R, Yusuf S; Indian Polycap Study (TIPS) Investigators. The need to test the theories behind the Polypill: rationale behind the Indian Polycap Study. Nat Clin Pract Cardiovasc Med. 2009 Feb;6(2):96-7. Epub 2008 Dec 23.
  • The Indian Polycap Study (TIPS); S Yusuf, P Pais, R Afzal, D Xavier, K Teo, J Eikelboom, A Sigamani, V Mohan, R Gupta, N Thomas. Effects of a poly-capsule (PolycapTM) on risk factors in middle aged individuals without cardiovascular disease. Lancet; in press.