The Indian POLYCAP Study (TIPS)

Summary

STUDY TITLE A randomized double-blind controlled trial of the efficacy and safety of the POLYCAP® versus its components in subjects aged 45 to 80 years of age with at least one additional cardiovascular risk factor.

STUDY OBJECTIVES This study is designed to assess the efficacy and safety of the POLYCAP®, a fixed dose combinationcontaining 5 drugs (an antiplatelet drug; 3 blood pressure lowering agents, a beta blocker, an ACE inhibitor, a diuretic and a statin.

STUDY DESIGN

Randomized controlled double-blind trial of the POLYCAP® versus its components in eight formulations.

STUDY POPULATION Subjects between 45 and 80 years of age, with at least one additional CVD risk factor.

INVESTIGATIONAL PRODUCTS Composition POLYCAP® and its comparators FOLLOW UP The total duration of follow up will be 4 months, from the start of study medication.. Subjects will take study medication for 3 months. There will be a final follow up visit 1 month after stopping the study medication.

There will be five follow up visits, the first 7 - 10 days after starting study medication and thereafter monthly visits for 4 months. Subjects taking any of the study medications prior to enrolment will have one or more additional visits during a defined wash out and before enrolment.

OUTCOME MEASURES Mean difference of change in BP, LDL and urinary thromboxane at the end of the three month period.

STATISTICAL ISSUES Non-inferiority evaluation of the POLYCAP in modifying BP, lipids and platelet activity \[as measured by urinary thromboxane\] when compared with its different components in eight different formulations.

Conditions

• Cardiovascular Diseases

Interventions

DRUG

Thiazides

Capsule (blinded) oral administration once daily for 12 weeks

DRUG

Ramipril with Thiazide

Capsule (blinded) oral administration 12 weeks

DRUG

Thiazide plus atenolol

Caspule (blinded) for oral administration once daily for 12 weeks

DRUG

Ramipril plus atenolol

Capsule ( blinded) for oral administration once daily for 12 weeks

DRUG

Ramipril plus atenolol plus thiazide

Capsule (blinded) for oral administration once daily for 12 weeeks

DRUG

POLYCAP

Capsule for Oral Administration once daily for 12 weeks

DRUG

Thiazide + Ramipril+Atenolol+Aspirin

Capsule (Blinded) for oral administration once daily for 12 weeks

DRUG

Simvastatin

Capsule (Blinded) for oral administration once daily for 12 weeks

DRUG

aspirin

capsule (Blinded) for oral administration once daily for 12 weeks

Sponsors & Collaborators

• Cadila Pharnmaceuticals

  collaborator INDUSTRY

• Population Health Research Institute

  collaborator OTHER

• St. John's Research Institute

  lead OTHER

Principal Investigators

• Prem Pais, MD Medicinie · Dean, Professor of Medicine, St Johns Medical College, Head Division of Clinical Trials St John's Research Institute, Bangalore, India

• Denis Xavier, MD Pharmac · HOPE Research Scholar, Department of Medicine, PHRI, McMaster University, Hamilton, ON, Canada,

• Salim Yusuf, DPhil,FRCPC,FRSC · Director, Population Health Research Institute, Mc Master University, Hamilton, ON, CANADA

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-03-31

Primary Completion

2008-10-31

Completion

2008-10-31

Countries

• India

Study Locations