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

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00739050
First received: August 19, 2008
Last updated: November 16, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: simvastatin
Drug: Comparator: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment. [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    The study was terminated; no outcome measure data analyses were conducted.


Secondary Outcome Measures:
  • Change in Total Cholesterol From Baseline at Week 12 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    The study was terminated; no outcome measure data analyses were conducted.


Enrollment: 4
Study Start Date: August 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739050

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00739050     History of Changes
Other Study ID Numbers: MK-0733-271, 2008_021
Study First Received: August 19, 2008
Results First Received: August 26, 2010
Last Updated: November 16, 2010
Health Authority: Mexico: Ministry of Health

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 22, 2014