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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00519363 |
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Date of registration:
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20/08/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors
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Scientific title:
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Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors. |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00519363 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Nabih I Abdou, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Center for Rheumatic Disease, Allergy, and Immunology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18-60, female
- have at least four ACR criteria for SLE
- SLEDAI score > 4
- LDL cholesterol level from 100-190mg/dl
Exclusion Criteria:
- Pregnant, lactating, or wanting to become pregnant
- unable to take atorvastatin due to allergy, liver disease, elevated lever function
test, myositis, or eleveated CPK
- already on lipid lowering therapy
- participating in another lupus study
- on drugs such as: amiodarone, clarithromycin, clclosporine, erythromycin,
itraconazole, ketoconazole, nefazodone, verapamil, protease inhibitors, niacin,
digoxin, cholestryrmine, colestipol
- has a diagnosis of myositis
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: atorvastatin
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Primary Outcome(s)
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decrease the SLEDAI level of female lupus patients, down regulate the TLR 2,4, and 9.
[Time Frame: 3 months]
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Secondary Outcome(s)
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lower lipid levels in female lupus patients
[Time Frame: 3 months]
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Secondary ID(s)
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Hospital
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Saint
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06-316
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Grant
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Luke's
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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