Cardiovascular Diseases
Conditions
Keywords
POLYCAP, Primary Prevention,CVD
Brief 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.
Interventions
DRUGThiazides
Capsule (blinded) oral administration once daily for 12 weeks
DRUGRamipril with Thiazide
Capsule (blinded) oral administration 12 weeks
DRUGThiazide plus atenolol
Caspule (blinded) for oral administration once daily for 12 weeks
DRUGRamipril plus atenolol
Capsule ( blinded) for oral administration once daily for 12 weeks
DRUGRamipril plus atenolol plus thiazide
Capsule (blinded) for oral administration once daily for 12 weeeks
DRUGPOLYCAP
Capsule for Oral Administration once daily for 12 weeks
DRUGThiazide + Ramipril+Atenolol+Aspirin
Capsule (Blinded) for oral administration once daily for 12 weeks
DRUGSimvastatin
Capsule (Blinded) for oral administration once daily for 12 weeks
DRUGaspirin
capsule (Blinded) for oral administration once daily for 12 weeks
Sponsors
Cadila Pharnmaceuticals
Population Health Research Institute
St. John's Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in blood Pressure | 12 weeks |
| reduction in Heart Rate | 12 weeks |
| modify lipids | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Platelet aggregation | 12 weks |
Countries
India
Outcome results
None listed