Status:
COMPLETED
Comparative Atorvastatin Pleiotropic Effects
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborating Sponsors:
MDS Pharma Services
Bio-Inova Life Sciences International
Conditions:
Coronary Arteriosclerosis
Hypercholesterolemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The primary objective of the study is to evaluate the efficacy of atorvastatin 80 mg daily as compared to atorvastatin 10 mg daily in reducing C-reactive protein levels over a 26-week treatment period...
Eligibility Criteria
Inclusion
- Male or female subjects of age of majority to \< 80 years
- Subjects with LDL-C \> 0.5 g/L (1.29 mmol/L) and \< 1.5 g/L (3.87 mmol/L), TG \< 4.00 g/L (4.56 mmol/L) and hs-CRP \>1.5 mg/L and \< 15 mg/L
- Subjects with a documented coronary artery disease.
Exclusion
- Female subjects of childbearing potential without contraception
- Subjects with secondary hyperlipidemia
- Diabetic subjects receiving insulin
- Subjects with a contra-indication to statin therapy.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00163202
Start Date
June 1 2002
End Date
August 1 2005
Last Update
February 18 2021
Active Locations (74)
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1
Pfizer Investigational Site
Calgary, Alberta, Canada, T2E 7C5
2
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6G 2S2
3
Pfizer Investigational Site
Vancouver, British Columbia, Canada, v6z 1y6
4
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3E 0Z3