The Indian POLYCAP Study (TIPS) - Full Text View

Sponsors and Collaborators:	St. John's Research Institute 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

Drug Information available for: Simvastatin Ramipril Acetylsalicylic acid Atenolol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
1, POLYCAP: Experimental Combination of 3 anti hypertensives, lipid lowering agent and anti platelet agent	Drug: POLYCAP Capsule for Oral Administration once daily for 12 weeks
2 B: Active Comparator Diuretic antihypertensive	Drug: Thiazides Capsule (blinded) oral administration once daily for 12 weeks
3 C: Active Comparator Thiazide plus Angiotensis converting enzyme inhibitor - combination antihypertensive.	Drug: Ramipril with Thiazide Capsule (blinded) oral administration 12 weeks
4 D: Active Comparator Diuretic with Beta blocker combination antihypertensive	Drug: Thiazide plus atenolol Caspule (blinded) for oral administration once daily for 12 weeks
5, E: Active Comparator ACE inhibitor plus Beta blocker combination antihypertensive	Drug: Ramipril plus atenolol Capsule ( blinded) for oral administration once daily for 12 weeks
6, F: Active Comparator 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
7,G: Active Comparator Combination of ACE inhibitor, betablocker, diuretic and Antiplatelet	Drug: Thiazide + Ramipril+Atenolol+Aspirin Capsule (Blinded) for oral administration once daily for 12 weeks
8,H: Active Comparator Lipid lowering agent	Drug: Simvastatin Capsule (Blinded) for oral administration once daily for 12 weeks
9,A: Active Comparator 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

Locations

India, KARNATAKA
St John's Medical College Hospital, Department of Medicine
BANGALORE, KARNATAKA, India, 560034
India, Karnataka
ST JOHN'S MEDICAL COLLEGE HOSPITAL, Dept of Cardiology
Bangalore, Karnataka, India, 560 034
India, TAMIL NADU
Christian Medical College Hospital
VELLORE, TAMIL NADU, 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

More 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

Responsible Party:	Division of Clinical Trials, St. John's Research Institute ( Project Director, The Indian Polycap Study Steering Comittee. )
Study ID Numbers:	Rx-Medical-CVS-06-01
Study First Received:	February 14, 2007
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00443794
Health Authority:	India: Ministry of Health

Keywords provided by St. John's Research Institute:

POLYCAP, Primary Prevention,CVD

Study placed in the following topic categories:

Aspirin
Simvastatin
Atenolol
Ramipril

Additional relevant MeSH terms:

Antimetabolites
Anti-Inflammatory Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Sensory System Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Adrenergic beta-Antagonists
Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Diseases

Anti-Arrhythmia Agents
Analgesics
Sympatholytics
Antilipemic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anticholesteremic Agents
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Analgesics, Non-Narcotic
Autonomic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009