Status:
COMPLETED
Guidelines Based Undertaking for Improvement in Dyslipidemia Related Events (GUIDE )
Lead Sponsor:
Canadian Heart Research Centre
Collaborating Sponsors:
Merck Frosst Canada Ltd.
Schering-Plough
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Brief Summary
This is a multi-center, open label observational study conducted over 26 weeks. Approximately 2,500 high-risk patients with an elevated LDL-C level (\> 2.5 mmol/L) will be enrolled. Patients meeting ...
Detailed Description
Overview This is a Quality Enhancement Research Initiative (QERI) whereby physicians are provided guidelines and easy to follow steps for their achievement.. Approximately 2,500 high-risk patients wi...
Eligibility Criteria
Inclusion
- Patient is male or female older 18 years of age.
- Patients with a diagnosis of primary hypercholesterolemia and who are defined as being "high risk" (10-year risk of coronary artery disease greater than 20 % based on the Framingham model and history of cardiovascular disease or)
- Patients who have not reached their recommended LDL-C target levels of 2.5 mmol/L while on a statin alone.
- According to the judgment of the treating physician patient enrollment is in the best interest of the patient.
- Patient agrees to participate and signs an informed consent allowing follow up and sharing of patient related data.
Exclusion
- Individuals with poor mental function, drug or substance abuse, or individuals with unstable psychiatric illnesses, which, in the opinion of the investigator, may interfere with optimal participation in the observational study. Alcoholic substance abuse would be defined as a patient with alcohol consumption \> 14 drink per week. (A drink is: a can of beer, glass of wine, or single measure of spirits.)
- Patients who have been treated with any investigational drug within 30 days prior to Visit 1. (If \<30 days, contact the clinical monitor for a case-by-case evaluation.)
- Patients with clinically significant concomitant illnesses of liver, muscle or kidney abnormalities.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT00408057
Start Date
December 1 2005
End Date
November 1 2007
Last Update
May 14 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. MIchael's Hospital
Toronto, Ontario, Canada, m5g 2p9