The Indian POLYCAP Study (TIPS) - Full Text View

Sponsor:	St. John's Research Institute
Collaborators:	Cadila Pharnmaceuticals Population Health Research Institute
Information provided by:	St. John's Research Institute
ClinicalTrials.gov Identifier:	NCT00443794

Purpose

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	Intervention
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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Drug Information available for: Acetylsalicylic acid Atenolol Simvastatin Ramipril

U.S. FDA Resources

Further study details as provided by St. John's Research Institute:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Platelet aggregation [ Time Frame: 12 weks ] [ Designated as safety issue: No ]

Enrollment:	2050
Study Start Date:	March 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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 Antiplatelet	Drug: aspirin capsule (Blinded) for oral administration once daily for 12 weeks

Eligibility

Ages Eligible for Study:	45 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443794

Show 54 Study Locations

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

More Information

Additional Information:

Division of Clinical Trials , St John's Research Institute, Website This link exits the ClinicalTrials.gov site

Cadila Pharmaceuticals This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2009 Mar 30.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2008 Dec 23. No abstract available.

Responsible Party:	Project Director, The Indian Polycap Study Steering Comittee., Division of Clinical Trials, St. John's Research Institute
ClinicalTrials.gov Identifier:	NCT00443794 History of Changes
Other Study ID Numbers:	Rx-Medical-CVS-06-01
Study First Received:	February 14, 2007
Last Updated:	September 22, 2010
Health Authority:	India: Ministry of Health

Keywords provided by St. John's Research Institute:

POLYCAP, Primary Prevention,CVD

Additional relevant MeSH terms:

Cardiovascular Diseases
Aspirin
Atenolol
Ramipril
Simvastatin
Sodium Chloride Symporter Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents

ClinicalTrials.gov processed this record on February 09, 2012