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ISRCTN
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ISRCTN63412511
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ClinicalTrials.gov identifier
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Public title
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Effects of a three-month course of rosuvastatin in patients with Systemic Lupus Erythematosus
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Scientific title
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Acronym
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Rosuvastatin in SLE
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Serial number at source
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N/A
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Study hypothesis
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Systemic lupus erythematosus (SLE) is a rheumatologic multi-systemic auto-immune disease particularly affecting joints, skin and kidneys. The aim of this trial was to investigate the effects of rosuvastatin on markers of lipid metabolism and inflammatory parameters in patients with SLE.
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Ethics approval
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Ethics approval received from the Ethical Committee of the Slotervaart Hospital (The Netherlands) on the 29th November 2004.
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Study design
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Randomised, open-labelled, cross-over study
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Countries of recruitment
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The Netherlands
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Disease/condition/study domain
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Systemic lupus erythematosus
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Participants - inclusion criteria
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1. Patients with chronic, non-acute SLE
2. Greater than 18 years old, either sex
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Participants - exclusion criteria
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1. Use of statins
2. Pregnancy
3. Raised liver enzymes
4. Recent (less than three months) major surgery or myocardial infarction
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Anticipated start date
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01/01/2005
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Anticipated end date
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01/01/2008
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Status of trial
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Completed
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Patient information material
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Target number of participants
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19
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Interventions
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Rosuvastatin 10 mg once daily.
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Primary outcome measure(s)
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Measured at baseline and after three months of treatment:
1. Total cholesterol
2. Low density lipoprotein (LDL) cholesterol
3. C-reactive protein (CRP)
4. Tumour necrotising factor (TNF)
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Secondary outcome measure(s)
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Measured at baseline and after three months of treatment:
1. Interleukin-6 (IL6), interleukin-10 (IL10), interleukin-8 (IL8)
2. Complement C3 and C4q
3. Anti-double stranded deoxyribonucleic acid (anti-dsDNA)
4. Urine protein
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Sources of funding
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AstraZeneca (The Netherlands) - unrestricted research grant
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Trial website
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Publications
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Contact name
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Prof
Hugo
ten Cate
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Address
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Department of Internal Medicine
Academisch Ziekenhuis Maastricht
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City/town
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Maastricht
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Zip/Postcode
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6229 HX
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Country
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Netherlands
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Email
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H.Tencate@BIOCH.unimaas.nl
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Sponsor
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AstraZeneca (The Netherlands)
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Address
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Postbus 599
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City/town
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Zoetermeer
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Zip/Postcode
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2700 AN
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Country
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Netherlands
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Tel
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+31 (0)79 363 2222
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Fax
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+31 (0)79 363 2444
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Email
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info.nl@astrazeneca.com
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Sponsor website:
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http://www.astrazeneca.nl
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Date applied
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12/03/2008
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Last edited
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26/03/2008
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Date ISRCTN assigned
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26/03/2008
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