Back to resultsEffect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)
Primary Purpose
Systemic Lupus Erythematosus
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
simvastatin
Comparator: Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Arm 1: Drug
Arm 2: Placebo
Outcomes
Primary Outcome Measures
Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.
The study was terminated; no outcome measure data analyses were conducted.
Secondary Outcome Measures
Change in Total Cholesterol From Baseline at Week 12
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
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
The study was terminated; no outcome measure data analyses were conducted.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00739050
Brief Title
Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)
Official Title
Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Study Start Date
September 19, 2007 (Actual)
Primary Completion Date
February 1, 2008 (Actual)
Study Completion Date
February 1, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Arm 1: Drug
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Arm 2: Placebo
Intervention Type
Drug
Intervention Name(s)
simvastatin
Other Intervention Name(s)
Zocor, MK0733
Intervention Description
simvastatin 20mg daily at nights for 12 weeks. Tablets
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo
Intervention Description
placebo daily at nights for 12 weeks. Tablets
Primary Outcome Measure Information:
Title
Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.
Description
The study was terminated; no outcome measure data analyses were conducted.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in Total Cholesterol From Baseline at Week 12
Description
The study was terminated; no outcome measure data analyses were conducted.
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment
Description
The study was terminated; no outcome measure data analyses were conducted.
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment
Description
The study was terminated; no outcome measure data analyses were conducted.
Time Frame
Baseline and 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)
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