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

Phase 4TerminatedNCT00739050

Organon and Co4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

simvastatinDRUG

simvastatin 20mg daily at nights for 12 weeks. Tablets

Comparator: PlaceboDRUG

placebo daily at nights for 12 weeks. Tablets

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Time frame: Baseline and 12 weeks

Secondary Outcomes

Change in Total Cholesterol From Baseline at Week 12

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

Time frame: Baseline and 12 weeks

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.

Time frame: Baseline and 12 weeks

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.

Time frame: Baseline and 12 weeks

Data from ClinicalTrials.gov

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