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Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)

This study has been terminated.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00739050
First received: August 19, 2008
Last updated: November 16, 2010
Last verified: November 2010
History of Changes

August 19, 2008
November 16, 2010
August 2007
June 2009   (final data collection date for primary outcome measure)
Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment. [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
The study was terminated; no outcome measure data analyses were conducted.
Effect of Simvastatin on endothelial function in premenopausal women with systemic lupus erythematosus. [ Time Frame: 3 Month(s) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00739050 on ClinicalTrials.gov Archive Site
  • Change in Total Cholesterol From Baseline at Week 12 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    The study was terminated; no outcome measure data analyses were conducted.
  • Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    The study was terminated; no outcome measure data analyses were conducted.
  • Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    The study was terminated; no outcome measure data analyses were conducted.
Evaluation of lipid efficacy parameters. [ Time Frame: 3 Month(s) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)
Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus

Women with Systemic Lupus Erythematosus (SLE) are prone to cardiovascular disease. Early detection of improvement of endothelial function with simvastatin could be a clue for future intervention trials.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Systemic Lupus Erythematosus
  • Drug: simvastatin
    simvastatin 20mg daily at nights for 12 weeks. Tablets
    Other Names:
    • Zocor
    • MK0733
  • Drug: Comparator: Placebo
    placebo daily at nights for 12 weeks. Tablets
  • Experimental: 1
    Arm 1: Drug
    Intervention: Drug: simvastatin
  • Placebo Comparator: 2
    Arm 2: Placebo
    Intervention: Drug: Comparator: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female Patients Over 18 Years Old
  • Confirmed Systemic Lupus Erythematosus (SLE) diagnosis according to American College of Rheumatology (ACR)
  • Signed Informed Consent Form (ICF)

Exclusion Criteria:

  • Patients With LDL-C Below 90 mg/dL
  • Pregnant Or Breast Feeding
  • Diabetes Mellitus
  • Or Any Clinically Relevant Organ Disfunction
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00739050
MK-0733-271, 2008_021
Not Provided
Vice President of Late Stage Development, Merck Sharp & Dohme Corp.
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP