The Indian POLYCAP Study (TIPS)

September 22, 2010 updated by: St. John's Research Institute

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2050

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra Pradesh
      • Adoni, Andhra Pradesh, India
        • Gowri Gopal Nursing Home
      • Hyderabad, Andhra Pradesh, India
        • Apollo Hospital
      • Hyderabad, Andhra Pradesh, India
        • Care Hospital, Banjarahills
      • Hyderabad, Andhra Pradesh, India
        • Durga Bai Deshmuk Hospital
      • Hyderabad, Andhra Pradesh, India
        • Global Hospital
      • Hyderabad, Andhra Pradesh, India
        • Mahavir Hospital
      • Kurnool, Andhra Pradesh, India
        • Vijaya Durga Cardiac Centre
      • Kurnool, Andhra Pradesh, India
        • Vijaya Hospital
      • Secunderabad, Andhra Pradesh, India
        • Care Hospital
      • Secunderabad, Andhra Pradesh, India
        • Krishna Institute of medical sciences
      • Vishakapatnam, Andhra Pradesh, India
        • Care Hospital
    • Andhra pradesh
      • Adoni, Andhra pradesh, India
        • Aditya nursing Home
      • Hyderabad, Andhra pradesh, India
        • Care Hospital, Nampalli
    • Delhi
      • New Delhi, Delhi, India
        • Sri Ganga Ram Hospital
      • Noida, Delhi, India
        • Fortis Hospital
    • Gujrat
      • Ahmedabad, Gujrat, India
        • Care Cardiovascular Consultant
      • Ahmedabad, Gujrat, India
        • V S Hospital
      • Baroda, Gujrat, India
        • Dev Hospital and ICU
    • Karnataka
      • Bangalore, Karnataka, India, 560 034
        • ST JOHN'S MEDICAL COLLEGE HOSPITAL, Dept of Cardiology
      • Bangalore, Karnataka, India, 560034
        • St John'S Medical College Hospital, Department of Medicine
      • Bangalore, Karnataka, India
        • Mahaveer Jain Hospital
      • Bangalore, Karnataka, India
        • Workhardt Hospital
      • Belgaum, Karnataka, India
        • Belgaum Diabetes
      • Mysore, Karnataka, India
        • Vikaram Hospital and Health Care
      • Shimoga, Karnataka, India
        • Nanjappa Hospital
    • Kerala
      • Calicut, Kerala, India
        • Baby Memorial Hospital
      • Cochin, Kerala, India
        • Amrita Institute Of Medical Science
      • Thrissur, Kerala, India
        • West Fort Hospital
      • Trivandrum, Kerala, India
        • Kerala Institute of Medical Sciences
    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, India
        • Apex Research Center and Hospital
      • Indore, Madhya Pradesh, India
        • MGM
    • Maharastra
      • Mumbai, Maharastra, India
        • Bhatia Hospital
      • Mumbai, Maharastra, India
        • C H L Apollo Hospital
      • Mumbai, Maharastra, India
        • Health Harmony Hospital
      • Nagpur, Maharastra, India
        • Avanti Institute of Cardiology
      • Nagpur, Maharastra, India
        • Cresent Hospital and Research center
      • Pune, Maharastra, India
        • Poona Hospital
      • Wardha, Maharastra, India
        • Mahatma Gandhi Institute of Medical Sciences
    • Punjab
      • Ludhiana, Punjab, India
        • Sidhu Hospital
      • Patiala, Punjab, India
        • Sadbhavana Heart Institute
    • Rajasthan
      • Bikaner, Rajasthan, India
        • S P Medical College
      • Jaipur, Rajasthan, India
        • Monilek Hospital
      • Jaipur, Rajasthan, India
        • Tongia Heart Hospital
    • Tamil Nadu
      • Vellore, Tamil Nadu, India
        • Christian Medical College Hospital
    • Tamilnadu
      • Ambur, Tamilnadu, India
        • Bethesda Hospital
      • Chennai, Tamilnadu, India
        • Frontier Lifeline
      • Chennai, Tamilnadu, India
        • Madras Diabetic Research Foundation
      • Chennai, Tamilnadu, India
        • Rajamuthaiah Hospital, Annamalianagar
      • Chennai, Tamilnadu, India
        • Sri Ramachandra Hospital
      • Coimbatore, Tamilnadu, India
        • PSG Hospital
      • Trichy, Tamilnadu, India
        • Ramakrishna Nursing Home
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India
        • King George Hospital
      • Lucknow, Uttar Pradesh, India
        • Sanjay Gandhi PGMI
    • West Bengal
      • Kolkata, West Bengal, India
        • Peerless Hospital and BK Roy esearch Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1, POLYCAP
Combination of 3 anti hypertensives, lipid lowering agent and anti platelet agent
Drug: POLYCAP
Capsule for Oral Administration once daily for 12 weeks
Other Names:
  • Quintapill(R)
Active Comparator: 2 B
Diuretic antihypertensive
Drug: Thiazides
Capsule (blinded) oral administration once daily for 12 weeks
Active Comparator: 3 C
Thiazide plus Angiotensis converting enzyme inhibitor - combination antihypertensive.
Drug: Ramipril with Thiazide
Capsule (blinded) oral administration 12 weeks
Active Comparator: 4 D
Diuretic with Beta blocker combination antihypertensive
Drug: Thiazide plus atenolol
Caspule (blinded) for oral administration once daily for 12 weeks
Active Comparator: 5, E
ACE inhibitor plus Beta blocker combination antihypertensive
Drug: Ramipril plus atenolol
Capsule ( blinded) for oral administration once daily for 12 weeks
Active Comparator: 6, F
Combination antihypertensive of ACE inhibitor, diuretic and beta blocker
Drug: Ramipril plus atenolol plus thiazide
Capsule (blinded) for oral administration once daily for 12 weeeks
Active Comparator: 7,G
Combination of ACE inhibitor, betablocker, diuretic and Antiplatelet
Drug: Thiazide + Ramipril+Atenolol+Aspirin
Capsule (Blinded) for oral administration once daily for 12 weeks
Active Comparator: 8,H
Lipid lowering agent
Drug: Simvastatin
Capsule (Blinded) for oral administration once daily for 12 weeks
Active Comparator: 9,A
Antiplatelet
Drug: aspirin
capsule (Blinded) for oral administration once daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in blood Pressure
Time Frame: 12 weeks
12 weeks
reduction in Heart Rate
Time Frame: 12 weeks
12 weeks
modify lipids
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Platelet aggregation
Time Frame: 12 weks
12 weks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. John's Research Institute

Collaborators

Population Health Research Institute
Cadila Pharnmaceuticals

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

February 14, 2007

First Submitted That Met QC Criteria

March 5, 2007

First Posted (Estimate)

March 6, 2007

Study Record Updates

Last Update Posted (Estimate)

September 23, 2010

Last Update Submitted That Met QC Criteria

September 22, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rx-Medical-CVS-06-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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