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The Indian POLYCAP Study (TIPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00443794
Recruitment Status : Completed
First Posted : March 6, 2007
Last Update Posted : September 23, 2010
Cadila Pharnmaceuticals
Population Health Research Institute
Information provided by:
St. John's Research Institute

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.


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
Cardiovascular Diseases Drug: 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : March 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Arm Intervention/treatment
Experimental: 1, POLYCAP
Combination of 3 anti hypertensives, lipid lowering agent and anti platelet agent
Capsule for Oral Administration once daily for 12 weeks
Other Name: 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
Drug: aspirin
capsule (Blinded) for oral administration once daily for 12 weeks

Primary Outcome Measures :
  1. Reduction in blood Pressure [ Time Frame: 12 weeks ]
  2. reduction in Heart Rate [ Time Frame: 12 weeks ]
  3. modify lipids [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Platelet aggregation [ Time Frame: 12 weks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00443794

Hide Hide 54 study locations
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Aditya nursing Home
Adoni, Andhra pradesh, India
Gowri Gopal Nursing Home
Adoni, Andhra Pradesh, India
Apollo Hospital
Hyderabad, Andhra Pradesh, India
Care Hospital, Banjarahills
Hyderabad, Andhra Pradesh, India
Care Hospital, Nampalli
Hyderabad, Andhra pradesh, India
Durga Bai Deshmuk Hospital
Hyderabad, Andhra Pradesh, India
Global hospital
Hyderabad, Andhra Pradesh, India
Mahavir Hospital
Hyderabad, Andhra Pradesh, India
Vijaya Durga Cardiac Centre
Kurnool, Andhra Pradesh, India
Vijaya Hospital
Kurnool, Andhra Pradesh, India
Care Hospital
Secunderabad, Andhra Pradesh, India
Krishna Institute of Medical Sciences
Secunderabad, Andhra Pradesh, India
Care Hospital
Vishakapatnam, Andhra Pradesh, India
Sri Ganga Ram Hospital
New Delhi, Delhi, India
Fortis Hospital
Noida, Delhi, India
Care Cardiovascular Consultant
Ahmedabad, Gujrat, India
V S hospital
Ahmedabad, Gujrat, India
Dev Hospital and ICU
Baroda, Gujrat, India
Bangalore, Karnataka, India, 560 034
St John'S Medical College Hospital, Department of Medicine
Bangalore, Karnataka, India, 560034
Mahaveer Jain Hospital
Bangalore, Karnataka, India
Workhardt Hospital
Bangalore, Karnataka, India
Belgaum Diabetes
Belgaum, Karnataka, India
Vikaram Hospital and Health Care
Mysore, Karnataka, India
Nanjappa Hospital
Shimoga, Karnataka, India
Baby Memorial Hospital
Calicut, Kerala, India
Amrita Institute of medical Science
Cochin, Kerala, India
West Fort Hospital
Thrissur, Kerala, India
Kerala Institute of Medical sciences
Trivandrum, Kerala, India
Apex Research Center and Hospital
Bhopal, Madhya Pradesh, India
Indore, Madhya Pradesh, India
Bhatia Hospital
Mumbai, Maharastra, India
C H L Apollo Hospital
Mumbai, Maharastra, India
Health Harmony Hospital
Mumbai, Maharastra, India
Avanti Institute of Cardiology
Nagpur, Maharastra, India
Cresent Hospital and Research center
Nagpur, Maharastra, India
Poona Hospital
Pune, Maharastra, India
Mahatma Gandhi Institute of Medical Sciences
Wardha, Maharastra, India
Sidhu Hospital
Ludhiana, Punjab, India
Sadbhavana Heart Institute
Patiala, Punjab, India
S P Medical College
Bikaner, Rajasthan, India
Monilek Hospital
Jaipur, Rajasthan, India
Tongia Heart Hospital
Jaipur, Rajasthan, India
Christian Medical College Hospital
Vellore, Tamil Nadu, India
Bethesda Hospital
Ambur, Tamilnadu, India
Frontier Lifeline
Chennai, Tamilnadu, India
Madras Diabetic Research Foundation
Chennai, Tamilnadu, India
Rajamuthaiah Hospital, Annamalianagar
Chennai, Tamilnadu, India
Sri Ramachandra Hospital
Chennai, Tamilnadu, India
PSG Hospital
Coimbatore, Tamilnadu, India
Ramakrishna Nursing Home
Trichy, Tamilnadu, India
King George Hospital
Lucknow, Uttar Pradesh, India
Sanjay Gandhi PGMI
Lucknow, Uttar Pradesh, India
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
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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
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Project Director, The Indian Polycap Study Steering Comittee., Division of Clinical Trials, St. John's Research Institute Identifier: NCT00443794    
Other Study ID Numbers: Rx-Medical-CVS-06-01
First Posted: March 6, 2007    Key Record Dates
Last Update Posted: September 23, 2010
Last Verified: September 2010
Keywords provided by St. John's Research Institute:
POLYCAP, Primary Prevention,CVD
Additional relevant MeSH terms:
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Cardiovascular Diseases
Sodium Chloride Symporter Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Antihypertensive Agents
Anti-Arrhythmia Agents