The Indian POLYCAP Study (TIPS)

This study has been completed.
Sponsor:
Collaborators:
Cadila Pharnmaceuticals
Population Health Research Institute
Information provided by:
St. John's Research Institute
ClinicalTrials.gov Identifier:
NCT00443794
First received: February 14, 2007
Last updated: September 22, 2010
Last verified: September 2010

February 14, 2007
September 22, 2010
March 2007
October 2008   (final data collection date for primary outcome measure)
  • Reduction in blood Pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • reduction in Heart Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • modify lipids [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • 1] Is equivalent in reducing blood pressure when compared with its components containing three blood pressure lowering drugs used in combination
  • 3] Is equivalent in modifying lipids when compared with the lipid lowering drug alone.
  • The primary objective is, among subjects between 45 and 80 years of age and at least one additional CVD risk factor, to evaluate if the POLYCAP:
  • 4] Is equivalent in reducing platelet aggregation when compared with antiplatelet drug given alone.
  • 5] Has acceptable rates of adverse events.
Complete list of historical versions of study NCT00443794 on ClinicalTrials.gov Archive Site
Platelet aggregation [ Time Frame: 12 weks ] [ Designated as safety issue: No ]
The secondary objective is to evaluate if the POLYCAP is superior to its components containing a single BP lowering drug or two BP lowering drugs
Not Provided
Not Provided
 
The Indian POLYCAP Study (TIPS)
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cardiovascular Diseases
  • Drug: Thiazides
    Capsule (blinded) oral administration once daily for 12 weeks
  • Drug: Ramipril with Thiazide
    Capsule (blinded) oral administration 12 weeks
  • Drug: Thiazide plus atenolol
    Caspule (blinded) for oral administration once daily for 12 weeks
  • Drug: Ramipril plus atenolol
    Capsule ( blinded) for oral administration once daily for 12 weeks
  • Drug: Ramipril plus atenolol plus thiazide
    Capsule (blinded) for oral administration once daily for 12 weeeks
  • Drug: POLYCAP
    Capsule for Oral Administration once daily for 12 weeks
    Other Name: Quintapill(R)
  • Drug: Thiazide + Ramipril+Atenolol+Aspirin
    Capsule (Blinded) for oral administration once daily for 12 weeks
  • Drug: Simvastatin
    Capsule (Blinded) for oral administration once daily for 12 weeks
  • Drug: aspirin
    capsule (Blinded) for oral administration once daily for 12 weeks
  • Experimental: 1, POLYCAP
    Combination of 3 anti hypertensives, lipid lowering agent and anti platelet agent
    Intervention: Drug: POLYCAP
  • Active Comparator: 2 B
    Diuretic antihypertensive
    Intervention: Drug: Thiazides
  • Active Comparator: 3 C
    Thiazide plus Angiotensis converting enzyme inhibitor - combination antihypertensive.
    Intervention: Drug: Ramipril with Thiazide
  • Active Comparator: 4 D
    Diuretic with Beta blocker combination antihypertensive
    Intervention: Drug: Thiazide plus atenolol
  • Active Comparator: 5, E
    ACE inhibitor plus Beta blocker combination antihypertensive
    Intervention: Drug: Ramipril plus atenolol
  • Active Comparator: 6, F
    Combination antihypertensive of ACE inhibitor, diuretic and beta blocker
    Intervention: Drug: Ramipril plus atenolol plus thiazide
  • Active Comparator: 7,G
    Combination of ACE inhibitor, betablocker, diuretic and Antiplatelet
    Intervention: Drug: Thiazide + Ramipril+Atenolol+Aspirin
  • Active Comparator: 8,H
    Lipid lowering agent
    Intervention: Drug: Simvastatin
  • Active Comparator: 9,A
    Antiplatelet
    Intervention: Drug: aspirin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2050
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
45 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00443794
Rx-Medical-CVS-06-01
Yes
Project Director, The Indian Polycap Study Steering Comittee., Division of Clinical Trials, St. John's Research Institute
St. John's Research Institute
  • Cadila Pharnmaceuticals
  • Population Health Research Institute
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
St. John's Research Institute
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP