An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus
NCT00432354
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1. 16-80 years of age, fulfilling ACR criteria for the classification of SLE (no limit on disease duration)
2. Active disease status including (1) active nephritis with moderate proteinuria (between 1.0gm/day and 2.5gm/day) despite ongoing immunosuppressive therapy or (2) moderate active extra-renal component of the SLEDAI score in the range of 3 to 10. The SLE-DAI score should have been stable for at least two weeks prior to screening.
3. The type and number immunosuppressive agents were not changed in recent one months
1. inability to give informed consent;
2. myositis (CK>3×normal value);
3. dialysis or serum creatinin>2.5mg/dL;
4. abnormal liver function (ALT>3×normal value);
5. pregnant or breastfeeding;
6. life-threatening illness that would interfere with ability to complete the study;
7. current drug or alcohol abuse
8. Already under statin therapy
9. Active SLE disease need added new immunosuppressive agent or increased current drug
dosage for more than 50%.
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Descriptive Information | ||||
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Brief Title ICMJE | An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus | |||
Official Title ICMJE | Not Provided | |||
Brief Summary | The aim of this study is to to determine whether atorvastatin 40mg per day is effective in the treatment of SLE. | |||
Detailed Description | Background: Statins are lipid-lower agents with pleiotropic effects. Beyond the traditional effect as inhibitors of 3-hydroxy-3methylglytaryl coenzyme A (HMG-CoA) reductase, it has anti-inflammatory and immunomodulatory properties. The administration of atorvastatin to lupus-prone model NZB/W F1 mice results in a significant reduction in serum IgG anti-dsDNA Abs and decreased proteinuria. In a pilot study with three patients with SLE, simvastatin induced rapid and significant reduction in proteinuria levels. However, further randomized double-blinded placebo-controlled study is pending. Objective: The goal of this study was to evaluate the clinical efficacy and laboratory effect of atorvastatin in SLE. Methods: Forty patients with SLE will randomize in two groups to receive atorvastatin or not as an adjuvant to immunosuppressive agent therapy. Patients who received atorvastatin for 6 months will stop atorvastatin for 8 weeks as a washout period. We will cross over the placebo and experimental groups, then given atorvastatin for another 6 months. Primary outcome is improvement of lupus disease status measured by SLEDAI and microcirculation improvement via nailfold capillaroscopy. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Systemic Lupus Erythematosus | |||
Intervention ICMJE | Drug: atorvastatin | |||
Study Arms ICMJE | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Enrollment ICMJE | 40 | |||
Original Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | March 2009 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 16 Years to 80 Years (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Taiwan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00432354 | |||
Other Study ID Numbers ICMJE | DTCRD 96-03 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Buddhist Tzu Chi General Hospital | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Buddhist Tzu Chi General Hospital | |||
Verification Date | March 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |