Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432354
Status:
UNKNOWN
Last Update Posted:
2007-03-20
First Post:
2007-02-06
Brief Title:
An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus
Sponsor:
Buddhist Tzu Chi General Hospital
Organization:
Buddhist Tzu Chi General Hospital
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 NZBW 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None