The Indian POLYCAP Study (TIPS)

Study Overview
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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.

Official Title
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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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* 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


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1, POLYCAP<br>Combination of 3 anti hypertensives, lipid lowering agent and anti platelet agent | Drug: POLYCAP<br>* Capsule for Oral Administration once daily for 12 weeks<br>* Other names: Quintapill(R);|
| Active Comparator: 2 B<br>Diuretic antihypertensive | Drug: Thiazides<br>* Capsule (blinded) oral administration once daily for 12 weeks<br>|
| Active Comparator: 3 C<br>Thiazide plus Angiotensis converting enzyme inhibitor - combination antihypertensive. | Drug: Ramipril with Thiazide<br>* Capsule (blinded) oral administration 12 weeks<br>|
| Active Comparator: 4 D<br>Diuretic with Beta blocker combination antihypertensive | Drug: Thiazide plus atenolol<br>* Caspule (blinded) for oral administration once daily for 12 weeks<br>|
| Active Comparator: 5, E<br>ACE inhibitor plus Beta blocker combination antihypertensive | Drug: Ramipril plus atenolol<br>* Capsule ( blinded) for oral administration once daily for 12 weeks<br>|
| Active Comparator: 6, F<br>Combination antihypertensive of ACE inhibitor, diuretic and beta blocker | Drug: Ramipril plus atenolol plus thiazide<br>* Capsule (blinded) for oral administration once daily for 12 weeeks<br>|
| Active Comparator: 7,G<br>Combination of ACE inhibitor, betablocker, diuretic and Antiplatelet | Drug: Thiazide + Ramipril+Atenolol+Aspirin<br>* Capsule (Blinded) for oral administration once daily for 12 weeks<br>|
| Active Comparator: 8,H<br>Lipid lowering agent | Drug: Simvastatin<br>* Capsule (Blinded) for oral administration once daily for 12 weeks<br>|
| Active Comparator: 9,A<br>Antiplatelet | Drug: aspirin<br>* capsule (Blinded) for oral administration once daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in blood Pressure |  | 12 weeks | 
| reduction in Heart Rate |  | 12 weeks | 
| modify lipids |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet aggregation |  | 12 weks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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POLYCAP, Primary Prevention,CVD