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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,050

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline

Completed

Started Mar 2007

Geographic Reach

1 country

54 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

First Submitted

Initial submission to the registry

February 14, 2007

Completed

15 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2007

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed

Last Updated

September 23, 2010

Status Verified

September 1, 2010

Enrollment Period

1.6 years

First QC Date

February 14, 2007

Last Update Submit

September 22, 2010

Conditions

Cardiovascular Diseases

Keywords

POLYCAP, Primary Prevention,CVD

Outcome Measures

Primary Outcomes (3)

Reduction in blood Pressure
12 weeks
reduction in Heart Rate
12 weeks
modify lipids
12 weeks

Secondary Outcomes (1)

Platelet aggregation
12 weks

Study Arms (9)

1, POLYCAP

EXPERIMENTAL

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

Drug: POLYCAP

2 B

ACTIVE COMPARATOR

Diuretic antihypertensive

Drug: Thiazides

3 C

ACTIVE COMPARATOR

Thiazide plus Angiotensis converting enzyme inhibitor - combination antihypertensive.

Drug: Ramipril with Thiazide

4 D

ACTIVE COMPARATOR

Diuretic with Beta blocker combination antihypertensive

Drug: Thiazide plus atenolol

5, E

ACTIVE COMPARATOR

ACE inhibitor plus Beta blocker combination antihypertensive

Drug: Ramipril plus atenolol

6, F

ACTIVE COMPARATOR

Combination antihypertensive of ACE inhibitor, diuretic and beta blocker

Drug: Ramipril plus atenolol plus thiazide

7,G

ACTIVE COMPARATOR

Combination of ACE inhibitor, betablocker, diuretic and Antiplatelet

Drug: Thiazide + Ramipril+Atenolol+Aspirin

8,H

ACTIVE COMPARATOR

Lipid lowering agent

Drug: Simvastatin

9,A

ACTIVE COMPARATOR

Antiplatelet

Drug: aspirin

Interventions

ThiazidesDRUG

Capsule (blinded) oral administration once daily for 12 weeks

2 B

Ramipril with ThiazideDRUG

Capsule (blinded) oral administration 12 weeks

3 C

Thiazide plus atenololDRUG

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

4 D

Ramipril plus atenololDRUG

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

5, E

Ramipril plus atenolol plus thiazideDRUG

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

6, F

POLYCAPDRUG

Capsule for Oral Administration once daily for 12 weeks

Also known as: Quintapill(R)

1, POLYCAP

Thiazide + Ramipril+Atenolol+AspirinDRUG

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

7,G

SimvastatinDRUG

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

8,H

aspirinDRUG

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

9,A

Eligibility Criteria

Age45 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

St. John's Research Institutelead
Cadila Pharnmaceuticalscollaborator
Population Health Research Institutecollaborator

Study Sites (54)

Aditya nursing Home

Adoni, Andhra Pradesh, India

Location

Gowri Gopal Nursing Home

Adoni, Andhra Pradesh, India

Location

Apollo Hospital