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The Indian POLYCAP Study (TIPS)

Sponsor
St. John's Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00443794
Collaborator
Cadila Pharnmaceuticals (Industry), Population Health Research Institute (Other)
2,050
Enrollment
54
Locations
9
Arms
19.1
Duration (Months)
38
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
2050 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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 Start Date :
Mar 1, 2007
Actual Primary Completion Date :
Oct 1, 2008
Actual Study Completion Date :
Oct 1, 2008

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Reduction in blood Pressure [12 weeks]

    2. reduction in Heart Rate [12 weeks]

    3. modify lipids [12 weeks]

    Secondary Outcome Measures

    1. Platelet aggregation [12 weks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aditya nursing Home Adoni Andhra pradesh India
    2 Gowri Gopal Nursing Home Adoni Andhra Pradesh India
    3 Apollo Hospital Hyderabad Andhra Pradesh India
    4 Care Hospital, Banjarahills Hyderabad Andhra Pradesh India
    5 Care Hospital, Nampalli Hyderabad Andhra pradesh India
    6 Durga Bai Deshmuk Hospital Hyderabad Andhra Pradesh India
    7 Global hospital Hyderabad Andhra Pradesh India
    8 Mahavir Hospital Hyderabad Andhra Pradesh India
    9 Vijaya Durga Cardiac Centre Kurnool Andhra Pradesh India
    10 Vijaya Hospital Kurnool Andhra Pradesh India
    11 Care Hospital Secunderabad Andhra Pradesh India
    12 Krishna Institute of Medical Sciences Secunderabad Andhra Pradesh India
    13 Care Hospital Vishakapatnam Andhra Pradesh India
    14 Sri Ganga Ram Hospital New Delhi Delhi India
    15 Fortis Hospital Noida Delhi India
    16 Care Cardiovascular Consultant Ahmedabad Gujrat India
    17 V S hospital Ahmedabad Gujrat India
    18 Dev Hospital and ICU Baroda Gujrat India
    19 ST JOHN'S MEDICAL COLLEGE HOSPITAL, Dept of Cardiology Bangalore Karnataka India 560 034
    20 St John'S Medical College Hospital, Department of Medicine Bangalore Karnataka India 560034
    21 Mahaveer Jain Hospital Bangalore Karnataka India
    22 Workhardt Hospital Bangalore Karnataka India
    23 Belgaum Diabetes Belgaum Karnataka India
    24 Vikaram Hospital and Health Care Mysore Karnataka India
    25 Nanjappa Hospital Shimoga Karnataka India
    26 Baby Memorial Hospital Calicut Kerala India
    27 Amrita Institute of medical Science Cochin Kerala India
    28 West Fort Hospital Thrissur Kerala India
    29 Kerala Institute of Medical sciences Trivandrum Kerala India
    30 Apex Research Center and Hospital Bhopal Madhya Pradesh India
    31 MGM Indore Madhya Pradesh India
    32 Bhatia Hospital Mumbai Maharastra India
    33 C H L Apollo Hospital Mumbai Maharastra India
    34 Health Harmony Hospital Mumbai Maharastra India
    35 Avanti Institute of Cardiology Nagpur Maharastra India
    36 Cresent Hospital and Research center Nagpur Maharastra India
    37 Poona Hospital Pune Maharastra India
    38 Mahatma Gandhi Institute of Medical Sciences Wardha Maharastra India
    39 Sidhu Hospital Ludhiana Punjab India
    40 Sadbhavana Heart Institute Patiala Punjab India
    41 S P Medical College Bikaner Rajasthan India
    42 Monilek Hospital Jaipur Rajasthan India
    43 Tongia Heart Hospital Jaipur Rajasthan India
    44 Christian Medical College Hospital Vellore Tamil Nadu India
    45 Bethesda Hospital Ambur Tamilnadu India
    46 Frontier Lifeline Chennai Tamilnadu India
    47 Madras Diabetic Research Foundation Chennai Tamilnadu India
    48 Rajamuthaiah Hospital, Annamalianagar Chennai Tamilnadu India
    49 Sri Ramachandra Hospital Chennai Tamilnadu India
    50 PSG Hospital Coimbatore Tamilnadu India
    51 Ramakrishna Nursing Home Trichy Tamilnadu India
    52 King George Hospital Lucknow Uttar Pradesh India
    53 Sanjay Gandhi PGMI Lucknow Uttar Pradesh India
    54 Peerless Hospital and BK Roy esearch Center Kolkata West Bengal India

    Sponsors and Collaborators

    • St. John's Research Institute
    • Cadila Pharnmaceuticals
    • Population Health Research Institute

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00443794
    Other Study ID Numbers:
    • Rx-Medical-CVS-06-01
    First Posted:
    Mar 6, 2007
    Last Update Posted:
    Sep 23, 2010
    Last Verified:
    Sep 1, 2010
    Keywords provided by , ,
    POLYCAP, Primary Prevention,CVD
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Aspirin
    Atenolol
    Ramipril
    Simvastatin
    Sodium Chloride Symporter Inhibitors

    Study Results

    No Results Posted as of Sep 23, 2010