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The Indian POLYCAP Study (TIPS)

The Indian POLYCAP Study (TIPS)

Last Updated: 2010-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

2050 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1, POLYCAP

Combination of 3 anti hypertensives, lipid lowering agent and anti platelet agent

Group Type EXPERIMENTAL

POLYCAP

Intervention Type DRUG

Capsule for Oral Administration once daily for 12 weeks

2 B

Diuretic antihypertensive

Group Type ACTIVE_COMPARATOR

Thiazides

Intervention Type DRUG

Capsule (blinded) oral administration once daily for 12 weeks

3 C

Thiazide plus Angiotensis converting enzyme inhibitor - combination antihypertensive.

Group Type ACTIVE_COMPARATOR

Ramipril with Thiazide

Intervention Type DRUG

Capsule (blinded) oral administration 12 weeks

4 D

Diuretic with Beta blocker combination antihypertensive

Group Type ACTIVE_COMPARATOR

Thiazide plus atenolol

Intervention Type DRUG

Caspule (blinded) for oral administration once daily for 12 weeks

5, E

ACE inhibitor plus Beta blocker combination antihypertensive

Group Type ACTIVE_COMPARATOR

Ramipril plus atenolol

Intervention Type DRUG

Capsule ( blinded) for oral administration once daily for 12 weeks

6, F

Combination antihypertensive of ACE inhibitor, diuretic and beta blocker

Group Type ACTIVE_COMPARATOR

Ramipril plus atenolol plus thiazide

Intervention Type DRUG

Capsule (blinded) for oral administration once daily for 12 weeeks

7,G

Combination of ACE inhibitor, betablocker, diuretic and Antiplatelet

Group Type ACTIVE_COMPARATOR

Thiazide + Ramipril+Atenolol+Aspirin

Intervention Type DRUG

Capsule (Blinded) for oral administration once daily for 12 weeks

8,H

Lipid lowering agent

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

Capsule (Blinded) for oral administration once daily for 12 weeks

9,A

Antiplatelet

Group Type ACTIVE_COMPARATOR

aspirin

Intervention Type DRUG

capsule (Blinded) for oral administration once daily for 12 weeks

Interventions

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Thiazides

Capsule (blinded) oral administration once daily for 12 weeks

Intervention Type DRUG

Ramipril with Thiazide

Capsule (blinded) oral administration 12 weeks

Intervention Type DRUG

Thiazide plus atenolol

Caspule (blinded) for oral administration once daily for 12 weeks

Intervention Type DRUG

Ramipril plus atenolol

Capsule ( blinded) for oral administration once daily for 12 weeks

Intervention Type DRUG

Ramipril plus atenolol plus thiazide

Capsule (blinded) for oral administration once daily for 12 weeeks

Intervention Type DRUG

POLYCAP

Capsule for Oral Administration once daily for 12 weeks

Intervention Type DRUG

Thiazide + Ramipril+Atenolol+Aspirin

Capsule (Blinded) for oral administration once daily for 12 weeks

Intervention Type DRUG

Simvastatin

Capsule (Blinded) for oral administration once daily for 12 weeks

Intervention Type DRUG

aspirin

capsule (Blinded) for oral administration once daily for 12 weeks

Intervention Type DRUG

Other Intervention Names

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Quintapill(R)

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Division of Clinical Trials, St. John's Research Institute

Principal Investigators

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Prem Pais, MD Medicinie

Role: STUDY_CHAIR

Dean, Professor of Medicine, St Johns Medical College, Head Division of Clinical Trials St John's Research Institute, Bangalore, India

Denis Xavier, MD Pharmac

Role: STUDY_DIRECTOR

HOPE Research Scholar, Department of Medicine, PHRI, McMaster University, Hamilton, ON, Canada,

Salim Yusuf, DPhil,FRCPC,FRSC

Role: STUDY_CHAIR

Director, Population Health Research Institute, Mc Master University, Hamilton, ON, CANADA

Locations

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Aditya nursing Home

Adoni, Andhra Pradesh, India

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