The Indian POLYCAP Study (TIPS)

Condition(s) targeted: Cardiovascular Diseases

Intervention: Thiazides (Drug); Ramipril with Thiazide (Drug); Thiazide plus atenolol (Drug); Ramipril plus atenolol (Drug); Ramipril plus atenolol plus thiazide (Drug); POLYCAP (Drug); Thiazide + Ramipril+Atenolol+Aspirin (Drug); Simvastatin (Drug); aspirin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: St. John's Research Institute

Official(s) and/or principal investigator(s):
Prem Pais, MD Medicinie, Study Chair, Affiliation: Dean, Professor of Medicine, St Johns Medical College, Head Division of Clinical Trials St John's Research Institute, Bangalore, India
Denis Xavier, MD Pharmac, Study Director, Affiliation: HOPE Research Scholar, Department of Medicine, PHRI, McMaster University, Hamilton, ON, Canada,
Salim Yusuf, DPhil,FRCPC,FRSC, Study Chair, Affiliation: Director, Population Health Research Institute, Mc Master University, Hamilton, ON, CANADA

Overall contact:
Prem Pais, MD Medicine, Phone: +91 80 25523416, Ext: 207, Email: prempais@iphcr.res.in

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.

Official title: A Randomized Double Blind Controlled Trial of the Efficacy and Safety of POLYCAP (Quintapill)Versus Its Components in Subjects With at Least One Additional Cardiovascular Risk Factor

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Reduction in blood Pressure

reduction in Heart Rate

modify lipids

Secondary outcome: Platelet aggregation

Minimum age: 45 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age between 45 and 80 years

- At least any one of the following CVD risk factors:

- Stable type 2 diabetes mellitus or

- Hypertension or

- Current smoker or

- A waist to hip ratio > 0. 85 for women and >0. 9 for men or

- Elevated lipids.

- Informed consent.

Exclusion Criteria:

- On any of the study medications,

- Uncontrolled blood pressure,

- Symptomatic hypotension,

- Any clear indication or a contraindication to the use of any of the study

medications,

- History of coronary/cerebrovascular events,

- Pregnancy or lactating or women of child-bearing potential with inadequate

contraception and / or an inability to attend follow up visits.

Prem Pais, MD Medicine, Phone: +91 80 25523416, Ext: 207, Email: prempais@iphcr.res.in

St John's Medical College Hospital, Department of Medicine, BANGALORE, KARNATAKA 560034, India; Recruiting
GANAPATHY BANTWAL, MBBS,MD
SUDHA SURESH, PhD
GANAPATHY BANTWAL, MBBS,MD, Principal Investigator

ST JOHN'S MEDICAL COLLEGE HOSPITAL, Dept of Cardiology, Bangalore, Karnataka 560 034, India; Recruiting
Chandrakanth , MD, DM, Phone: +91 80 2206505324
Kiron Varghese, MD DM, Phone: 9845014311, Email: cardioresearch@gmail.com;shamiyengar@tochtelindia.net
CHANDRAKANTH, MD DM, Principal Investigator

Christian Medical College Hospital, VELLORE, TAMIL NADU, India; Recruiting
PRAKASH
NIHAL THOMAS, MBBS,MD, Principal Investigator

Division of Clinical Trials , St John's Research Institute, Website

Cadila Pharmaceuticals

Starting date: March 2007
Ending date: October 2008
Last updated: July 9, 2008