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

Organon

Status and phase: Terminated; Phase 4

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: simvastatin; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00739050

2008_021

0733-271

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Arm 1: Drug

Treatment:

Drug: simvastatin

2

Placebo Comparator group

Description:

Arm 2: Placebo

Treatment:

Drug: Comparator: Placebo