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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00739050
First Posted: August 21, 2008
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
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

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


Enrollment: 4
Actual Study Start Date: September 19, 2007
Study Completion Date: February 1, 2008
Primary Completion Date: February 1, 2008 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  Contacts and Locations
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.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00739050     History of Changes
Other Study ID Numbers: 0733-271
2008_021
First Submitted: August 19, 2008
First Posted: August 21, 2008
Results First Submitted: August 26, 2010
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