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

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

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 Overview

• Status: Terminated
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: simvastatin; Drug: Comparator: Placebo

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Arm 1: Drug	Drug: simvastatin; simvastatin 20mg daily at nights for 12 weeks. Tablets; Other Names: Zocor; MK0733
Placebo Comparator: 2; Arm 2: Placebo	Drug: Comparator: Placebo; placebo daily at nights for 12 weeks. Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: August 19, 2008
• First Submitted That Met QC Criteria: August 19, 2008
• First Posted (Estimate): August 21, 2008

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin
• Other Study ID Numbers: 0733-271; 2008_021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php