Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00739050

Purpose

Women with SLE are prone to cardiovascular disease. Early detection of improvement of endothelial function with simvastatin could be a clue for future intervention trials.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: simvastatin Drug: Comparator: Placebo (unspecified)	Phase IV

MedlinePlus related topics: Lupus

Drug Information available for: Simvastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus

Further study details as provided by Merck:

Primary Outcome Measures:

Effect of Simvastatin on endothelial function in premenopausal women with systemic lupus erythematosus. [ Time Frame: 3 Month(s) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluation of lipid efficacy parameters. [ Time Frame: 3 Month(s) ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	August 2007
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Arm 1: Drug	Drug: simvastatin simvastatin 20mg daily at nights for 12 weeks. Tablets
2: Placebo Comparator Arm 2: Placebo	Drug: Comparator: Placebo (unspecified) placebo daily at nights for 12 weeks. Tablets

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female Patients Over 18 Years Old
Confirmed SLE Diagnosis According To ACR
Signed Informed Consent Form (ICF)

Exclusion Criteria:

Patients With C-Ldl Below 90 Mg/Dl
Pregnant Or Breast Feeding
Diabetes Mellitus
Or Any Clinically Relevant Organ Disfunction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739050

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_021, MK0733-271
Study First Received:	August 19, 2008
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00739050
Health Authority:	Mexico: Ministry of Health

Study placed in the following topic categories:

Autoimmune Diseases
Lupus Erythematosus, Systemic
Simvastatin
Connective Tissue Diseases

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009