NCT00443794

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

Completed NA Last updated 22 September 2010

What this trial tests

NA trial testing Thiazides in Cardiovascular Diseases in 2,050 participants. Completed in 1 October 2008.

Timeline

1 March 2007

Primary endpoint
1 October 2008

1 October 2008

Quick facts

Lead sponsor	St. John's Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	2,050
Start date	1 March 2007
Primary completion	1 October 2008
Estimated completion	1 October 2008
Sites	54 locations across India

Drugs / interventions tested

• Thiazides
• Ramipril with Thiazide — full drug profile →
• Thiazide plus atenolol — full drug profile →
• Ramipril plus atenolol — full drug profile →
• Ramipril plus atenolol plus thiazide — full drug profile →
• POLYCAP
• Thiazide + Ramipril+Atenolol+Aspirin
• Simvastatin (simvastatin) — full drug profile →
• aspirin

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

St. John's Research Institute

Who can join

Adults 45 to 80, any sex, with Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Reduction in blood Pressure
  Time frame: 12 weeks
• reduction in Heart Rate
  Time frame: 12 weeks
• modify lipids
  Time frame: 12 weeks

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomised trial.
   Indian Polycap Study (TIPS), Yusuf S, Pais P, Afzal R, et al · · 2009 · cited 307× · PMID 19339045 · DOI 10.1016/s0140-6736(09)60611-5