NCT00443794

The Indian POLYCAP Study (TIPS)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,050 (actual)
• Sponsor: St. John's Research Institute · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-03-06
• Last updated: 2010-09-23

Locations

54 sites across 1 country: India