Clinical trial NCT00443794: The Indian POLYCAP Study (TIPS)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: POLYCAP, Primary Prevention,CVD
Lead sponsor: St. John's Research Institute
Sponsor class: OTHER
Collaborators: name: Cadila Pharnmaceuticals
name: Population Health Research Institute
First posted: 2007-03-06
Enrollment: 2050
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Reduction in blood Pressure
timeFrame: 12 weeks
measure: reduction in Heart Rate
timeFrame: 12 weeks
measure: modify lipids
timeFrame: 12 weeks
Secondary outcomes:
measure: Platelet aggregation
timeFrame: 12 weks
Other outcomes:
Locations:
city: Adoni
country: India
facility: Aditya nursing Home
state: Andhra pradesh
city: Adoni
country: India
facility: Gowri Gopal Nursing Home
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Apollo Hospital
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Care Hospital, Banjarahills
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Care Hospital, Nampalli
state: Andhra pradesh
city: Hyderabad
country: India
facility: Durga Bai Deshmuk Hospital
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Global hospital
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Mahavir Hospital
state: Andhra Pradesh
city: Kurnool
country: India
facility: Vijaya Durga Cardiac Centre
state: Andhra Pradesh
city: Kurnool
country: India
facility: Vijaya Hospital
state: Andhra Pradesh
city: Secunderabad
country: India
facility: Care Hospital
state: Andhra Pradesh
city: Secunderabad
country: India
facility: Krishna Institute of Medical Sciences
state: Andhra Pradesh
city: Vishakapatnam
country: India
facility: Care Hospital
state: Andhra Pradesh
city: New Delhi
country: India
facility: Sri Ganga Ram Hospital
state: Delhi
city: Noida
country: India
facility: Fortis Hospital
state: Delhi
city: Ahmedabad
country: India
facility: Care Cardiovascular Consultant
state: Gujrat
city: Ahmedabad
country: India
facility: V S hospital
state: Gujrat
city: Baroda
country: India
facility: Dev Hospital and ICU
state: Gujrat
city: Bangalore
country: India
facility: ST JOHN'S MEDICAL COLLEGE HOSPITAL, Dept of Cardiology
state: Karnataka
city: Bangalore
country: India
facility: St John'S Medical College Hospital, Department of Medicine
state: Karnataka
city: Bangalore
country: India
facility: Mahaveer Jain Hospital
state: Karnataka
city: Bangalore
country: India
facility: Workhardt Hospital
state: Karnataka
city: Belgaum
country: India
facility: Belgaum Diabetes
state: Karnataka
city: Mysore
country: India
facility: Vikaram Hospital and Health Care
state: Karnataka
city: Shimoga
country: India
facility: Nanjappa Hospital
state: Karnataka
city: Calicut
country: India
facility: Baby Memorial Hospital
state: Kerala
city: Cochin
country: India
facility: Amrita Institute of medical Science
state: Kerala
city: Thrissur
country: India
facility: West Fort Hospital
state: Kerala
city: Trivandrum
country: India
facility: Kerala Institute of Medical sciences
state: Kerala
city: Bhopal
country: India
facility: Apex Research Center and Hospital
state: Madhya Pradesh
city: Indore
country: India
facility: MGM
state: Madhya Pradesh
city: Mumbai
country: India
facility: Bhatia Hospital
state: Maharastra
city: Mumbai
country: India
facility: C H L Apollo Hospital
state: Maharastra
city: Mumbai
country: India
facility: Health Harmony Hospital
state: Maharastra
city: Nagpur
country: India
facility: Avanti Institute of Cardiology
state: Maharastra
city: Nagpur
country: India
facility: Cresent Hospital and Research center
state: Maharastra
city: Pune
country: India
facility: Poona Hospital
state: Maharastra
city: Wardha
country: India
facility: Mahatma Gandhi Institute of Medical Sciences
state: Maharastra
city: Ludhiana
country: India
facility: Sidhu Hospital
state: Punjab
city: Patiala
country: India
facility: Sadbhavana Heart Institute
state: Punjab
city: Bikaner
country: India
facility: S P Medical College
state: Rajasthan
city: Jaipur
country: India
facility: Monilek Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Tongia Heart Hospital
state: Rajasthan
city: Vellore
country: India
facility: Christian Medical College Hospital
state: Tamil Nadu
city: Ambur
country: India
facility: Bethesda Hospital
state: Tamilnadu
city: Chennai
country: India
facility: Frontier Lifeline
state: Tamilnadu
city: Chennai
country: India
facility: Madras Diabetic Research Foundation
state: Tamilnadu
city: Chennai
country: India
facility: Rajamuthaiah Hospital, Annamalianagar
state: Tamilnadu
city: Chennai
country: India
facility: Sri Ramachandra Hospital
state: Tamilnadu
city: Coimbatore
country: India
facility: PSG Hospital
state: Tamilnadu
city: Trichy
country: India
facility: Ramakrishna Nursing Home
state: Tamilnadu
city: Lucknow
country: India
facility: King George Hospital
state: Uttar Pradesh
city: Lucknow
country: India
facility: Sanjay Gandhi PGMI
state: Uttar Pradesh
city: Kolkata
country: India
facility: Peerless Hospital and BK Roy esearch Center
state: West Bengal
Study officials:
affiliation: Dean, Professor of Medicine, St Johns Medical College, Head Division of Clinical Trials St John's Research Institute, Bangalore, India
name: Prem Pais, MD Medicinie
role: STUDY_CHAIR
affiliation: HOPE Research Scholar, Department of Medicine, PHRI, McMaster University, Hamilton, ON, Canada,
name: Denis Xavier, MD Pharmac
role: STUDY_DIRECTOR
affiliation: Director, Population Health Research Institute, Mc Master University, Hamilton, ON, CANADA
name: Salim Yusuf, DPhil,FRCPC,FRSC
role: STUDY_CHAIR
References:
citation: Indian Polycap Study (TIPS); Yusuf S, Pais P, Afzal R, Xavier D, Teo K, Eikelboom J, Sigamani A, Mohan V, Gupta R, Thomas N. Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomised trial. Lancet. 2009 Apr 18;373(9672):1341-51. doi: 10.1016/S0140-6736(09)60611-5. Epub 2009 Mar 30.
citation: Xavier D, Pais P, Sigamani A, Pogue J, Afzal R, Yusuf S; Indian Polycap Study (TIPS) Investigators. The need to test the theories behind the Polypill: rationale behind the Indian Polycap Study. Nat Clin Pract Cardiovasc Med. 2009 Feb;6(2):96-7. doi: 10.1038/ncpcardio1438. Epub 2008 Dec 23. No abstract available.