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”

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.

Study Type: Interventional

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

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: Thiazides
  • Capsule (blinded) oral administration once daily for 12 weeks
• Drug: Ramipril with Thiazide
  • Capsule (blinded) oral administration 12 weeks
• Drug: Thiazide plus atenolol
  • Caspule (blinded) for oral administration once daily for 12 weeks
• Drug: Ramipril plus atenolol
  • Capsule ( blinded) for oral administration once daily for 12 weeks
• Drug: Ramipril plus atenolol plus thiazide
  • Capsule (blinded) for oral administration once daily for 12 weeeks
• Drug: POLYCAP
  • Capsule for Oral Administration once daily for 12 weeks
• Drug: Thiazide + Ramipril+Atenolol+Aspirin
  • Capsule (Blinded) for oral administration once daily for 12 weeks
• Drug: Simvastatin
  • Capsule (Blinded) for oral administration once daily for 12 weeks
• Drug: aspirin
  • capsule (Blinded) for oral administration once daily for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1, POLYCAP
  • Combination of 3 anti hypertensives, lipid lowering agent and anti platelet agent
• Active Comparator: 2 B
  • Diuretic antihypertensive
• Active Comparator: 3 C
  • Thiazide plus Angiotensis converting enzyme inhibitor - combination antihypertensive.
• Active Comparator: 4 D
  • Diuretic with Beta blocker combination antihypertensive
• Active Comparator: 5, E
  • ACE inhibitor plus Beta blocker combination antihypertensive
• Active Comparator: 6, F
  • Combination antihypertensive of ACE inhibitor, diuretic and beta blocker
• Active Comparator: 7,G
  • Combination of ACE inhibitor, betablocker, diuretic and Antiplatelet
• Active Comparator: 8,H
  • Lipid lowering agent
• Active Comparator: 9,A
  • Antiplatelet

Primary Measures

• Reduction in blood Pressure
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• reduction in Heart Rate
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• modify lipids
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Secondary Measures

• Platelet aggregation
  • Time Frame: 12 weks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: St. John's Research Institute

Overall Clinical Trial Officials and Contacts

Prem Pais, MD Medicinie Study Chair Dean, Professor of Medicine, St Johns Medical College, Head Division of Clinical Trials St John's Research Institute, Bangalore, India  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00443794

Study ID Number: Rx-Medical-CVS-06-01

ClinicalTrials.gov Identifier: NCT00443794

Health Authority: India: Ministry of Health

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

Cadila Pharmaceuticals