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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014