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

Organon and Co0 sites4 target enrollmentSeptember 19, 2007

ConditionsSystemic Lupus Erythematosus

Interventionssimvastatin

Drugssimvastatin Comparator: Placebo

Overview

Phase: Phase 4
Intervention: simvastatin
Conditions: Systemic Lupus Erythematosus
Sponsor: Organon and Co
Enrollment: 4
Primary Endpoint: Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 19, 2007

End Date

February 1, 2008

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

1

Arm 1: Drug

Intervention: simvastatin

Outcomes

Primary Outcomes

Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.

Time Frame: Baseline and 12 weeks

The study was terminated; no outcome measure data analyses were conducted.

Secondary Outcomes

Change in Total Cholesterol From Baseline at Week 12(Baseline and 12 weeks)
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment(Baseline and 12 weeks)
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment(Baseline and 12 weeks)