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.
Phase:
N/A
Details
Lead Sponsor:
St. John's Research Institute
Collaborators:
Cadila Pharnmaceuticals Population Health Research Institute