Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)
2 other identifiers
interventional
4
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2007
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 19, 2008
CompletedFirst Posted
Study publicly available on registry
August 21, 2008
CompletedResults Posted
Study results publicly available
December 16, 2010
CompletedMay 23, 2024
February 1, 2022
5 months
August 19, 2008
August 26, 2010
May 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.
The study was terminated; no outcome measure data analyses were conducted.
Baseline and 12 weeks
Secondary Outcomes (3)
Change in Total Cholesterol From Baseline at Week 12
Baseline and 12 weeks
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment
Baseline and 12 weeks
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment
Baseline and 12 weeks
Study Arms (2)
1
EXPERIMENTALArm 1: Drug
2
PLACEBO COMPARATORArm 2: Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Female Patients Over 18 Years Old
- Confirmed Systemic Lupus Erythematosus (SLE) diagnosis according to American College of Rheumatology (ACR)
- Signed Informed Consent Form (ICF)
You may not qualify if:
- Patients With LDL-C Below 90 mg/dL
- Pregnant Or Breast Feeding
- Diabetes Mellitus
- Or Any Clinically Relevant Organ Disfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The Investigator was not able to recruit the required patients and was not able to get the necessary equipment. The protocol was terminated for Administrative Reasons.
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2008
First Posted
August 21, 2008
Study Start
September 19, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
May 23, 2024
Results First Posted
December 16, 2010
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share