The Indian POLYCAP Study (TIPS)

St. John's Research Institute

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Drug: Thiazide + Ramipril+Atenolol+Aspirin; Drug: Ramipril plus atenolol; Drug: Thiazide plus atenolol; Drug: Simvastatin; Drug: Thiazides; Drug: aspirin; Drug: Ramipril with Thiazide; Drug: Ramipril plus atenolol plus thiazide; Drug: POLYCAP

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00443794

Rx-Medical-CVS-06-01

Details and patient eligibility

About

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.

Enrollment: 2,050 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,050 participants in 9 patient groups

1, POLYCAP

Experimental group

Description:

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

Treatment:

Drug: POLYCAP

2 B

Active Comparator group

Description:

Diuretic antihypertensive

Treatment:

Drug: Thiazides

3 C

Active Comparator group

Description:

Thiazide plus Angiotensis converting enzyme inhibitor - combination antihypertensive.

Treatment:

Drug: Ramipril with Thiazide

4 D

Active Comparator group

Description:

Diuretic with Beta blocker combination antihypertensive

Treatment:

Drug: Thiazide plus atenolol

5, E

Active Comparator group

Description:

ACE inhibitor plus Beta blocker combination antihypertensive

Treatment:

Drug: Ramipril plus atenolol

6, F

Active Comparator group

Description:

Combination antihypertensive of ACE inhibitor, diuretic and beta blocker

Treatment:

Drug: Ramipril plus atenolol plus thiazide

7,G

Active Comparator group

Description:

Combination of ACE inhibitor, betablocker, diuretic and Antiplatelet

Treatment:

Drug: Thiazide + Ramipril+Atenolol+Aspirin

8,H

Active Comparator group

Description:

Lipid lowering agent

Treatment:

Drug: Simvastatin

9,A

Active Comparator group

Description:

Antiplatelet

Treatment:

Drug: aspirin