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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 19, 2008

Last Updated Date

August 19, 2008

Start Date ^†

August 2007

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus

Official Title ^†

Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Systemic Lupus Erythematosus

Intervention ^†

Drug: simvastatin
Drug: Comparator: Placebo (unspecified)

Study Arms / Comparison Groups

Experimental: Arm 1: Drug
Placebo Comparator: Arm 2: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

Estimated Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00739050

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Secondary IDs ^††

MK0733-271

Study Sponsor ^†

Merck

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

August 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.