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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

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ClinicalTrials.gov Identifier: NCT00866229
Recruitment Status : Unknown
Verified March 2009 by Ramathibodi Hospital.
Recruitment status was:  Recruiting
First Posted : March 20, 2009
Last Update Posted : March 20, 2009
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Ramathibodi Hospital

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, statin is used in restricted groups of rheumatologists due to awareness of side effects; myositis and hepatitis, that are frequently found in SLE patients more so than other groups of atherosclerosis patients and reporting data of autoimmune diseases that occur after statin use.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus High LDL Cholesterol Level Drug: Rosuvastatin Drug: Simvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in SLE Patients With Corticosteroid Therapy and High LDL Cholesterol Level
Study Start Date : April 2008
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : June 2010



Intervention Details:
  • Drug: Rosuvastatin
    10 mg per day for 12 weeks
  • Drug: Simvastatin
    20 mg per day


Primary Outcome Measures :
  1. Percentage reduction of LDL Cholesterol level [ Time Frame: 6 and 12 weeks ]

Secondary Outcome Measures :
  1. Proportion of patients that have transminitis, myositis or active SLE [ Time Frame: 6,12, 18 and 24 weeks ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00866229


Contacts
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Contact: Parawee Suwannalai, M.D. +31614364578 tepwa@mahidol.ac.th
Contact: Piyaporn Sirijanchun, M.D. +66816810700 tepsrc@mahidol.ac.th

Locations
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Thailand
Faculty of Medicine, Ramathibodi Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10240
Contact: Pintip Ngamjanyaporn, M.D.    +6622011477    pintiptip@yahoo.com   
Contact: Piyaporn Sirijanchun, M.D.    +6622011477    tepsrc@mahidol.ac.th   
Principal Investigator: Parawee Suwannalai, M.D.         
Sponsors and Collaborators
Ramathibodi Hospital
AstraZeneca
Investigators
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Principal Investigator: Parawee Suwannalai, M.D. Ramathibodi Hospital

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Responsible Party: Parawee Suwannalai , M.D., Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT00866229     History of Changes
Other Study ID Numbers: ID03-51-15
First Posted: March 20, 2009    Key Record Dates
Last Update Posted: March 20, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rosuvastatin Calcium
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors