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

Phase 4

Terminated

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: simvastatin

• Registration Number: NCT00739050
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-19
• Primary Completion: 2008-02-01
• Study Completion: 2008-02-01
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-21
• Results First Submitted: 2010-08-26
• Results First Submitted QC: 2010-11-16
• Results First Posted: 2010-12-16
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	simvastatin	Arm 1: Drug

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.	Baseline and 12 weeks	The study was terminated; no outcome measure data analyses were conducted.

Secondary Outcome Measures

Name	Time	Method
Change in Total Cholesterol From Baseline at Week 12	Baseline and 12 weeks	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	Baseline and 12 weeks	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	Baseline and 12 weeks	The study was terminated; no outcome measure data analyses were conducted.