Status:
UNKNOWN
Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in Systemic Lupus Erythematosus (SLE) Patients With Corticosteroid Therapy and High Low-Density Lipoprotein (LDL) Cholesterol Level
Lead Sponsor:
Ramathibodi Hospital
Collaborating Sponsors:
AstraZeneca
Conditions:
Systemic Lupus Erythematosus
High LDL Cholesterol Level
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Early statin therapy in SLE patients that have high cholesterol level and other atherosclerosis risk should reduce atherosclerosis and coronary artery events in later course of disease. By the way, st...
Eligibility Criteria
Inclusion
- SLE patients that on prednisolone more than 30 mg/day
- Normal liver faction: AST and ALT \< 80 mg/dl
- Normal muscle enzyme : CPK \< 100 U/L
- LDL cholesterol level \> 100 mg/dl
Exclusion
- Patients that was treated with pulse methylprednisolone or corticosteroid equivalent to prednisolone \> 1mg/kg/day at screening.
- Statin allergy
- On statin treatment before screening
- On cyclosporine, antifugal (azole group), antibiotics (macrolide group), rifampicin, warfarin, phenytoin
- Pregnancy
- Abnormal liver function: AST or ALT \> 80 mg/dl
- Abnormal muscle enzyme : CPK \> 300 U/L
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00866229
Start Date
April 1 2008
End Date
June 1 2010
Last Update
March 20 2009
Active Locations (1)
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1
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10240