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

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ClinicalTrials.gov Identifier: NCT00739050
Recruitment Status : Terminated
First Posted : August 21, 2008
Results First Posted : December 16, 2010
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: simvastatin Drug: Comparator: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus
Actual Study Start Date : September 19, 2007
Actual Primary Completion Date : February 1, 2008
Actual Study Completion Date : February 1, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Simvastatin
U.S. FDA Resources

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



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


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

  2. Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ]
    The study was terminated; no outcome measure data analyses were conducted.

  3. Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ]
    The study was terminated; no outcome measure data analyses were conducted.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739050


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00739050     History of Changes
Other Study ID Numbers: 0733-271
2008_021
First Posted: August 21, 2008    Key Record Dates
Results First Posted: December 16, 2010
Last Update Posted: May 5, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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


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
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors