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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00739050
• Other study ID #: 0733-271
• Secondary ID: 2008_021
• Status: Terminated
• Phase: Phase 4
• Start date: September 19, 2007
• Est. completion date: February 1, 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 1, 2008
• Est. primary completion date: February 1, 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• simvastatin
simvastatin 20mg daily at nights for 12 weeks. Tablets
• Comparator: Placebo
placebo daily at nights for 12 weeks. Tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.	The study was terminated; no outcome measure data analyses were conducted.	Baseline and 12 weeks
Secondary	Change in Total Cholesterol From Baseline at Week 12	The study was terminated; no outcome measure data analyses were conducted.	Baseline and 12 weeks
Secondary	Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment	The study was terminated; no outcome measure data analyses were conducted.	Baseline and 12 weeks
Secondary	Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment	The study was terminated; no outcome measure data analyses were conducted.	Baseline and 12 weeks