Status:
COMPLETED
The Indian POLYCAP Study (TIPS)
Lead Sponsor:
St. John's Research Institute
Collaborating Sponsors:
Cadila Pharnmaceuticals
Population Health Research Institute
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
45-80 years
Phase:
NA
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 cardiovascul...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
2050 Patients enrolled
Trial Details
Trial ID
NCT00443794
Start Date
March 1 2007
End Date
October 1 2008
Last Update
September 23 2010
Active Locations (54)
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1
Aditya nursing Home
Adoni, Andhra Pradesh, India
2
Gowri Gopal Nursing Home
Adoni, Andhra Pradesh, India
3
Apollo Hospital
Hyderabad, Andhra Pradesh, India
4
Care Hospital, Banjarahills
Hyderabad, Andhra Pradesh, India