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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00739050 |
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Date of registration:
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19/08/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)
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Scientific title:
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Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus |
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Date of first enrolment:
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September 19, 2007 |
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Target sample size:
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4 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00739050 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 4
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Merck Sharp & Dohme Corp. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: Comparator: Placebo
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Drug: simvastatin
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Primary Outcome(s)
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Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.
[Time Frame: Baseline and 12 weeks]
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Secondary Outcome(s)
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Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment
[Time Frame: Baseline and 12 weeks]
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Change in Total Cholesterol From Baseline at Week 12
[Time Frame: Baseline and 12 weeks]
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Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment
[Time Frame: Baseline and 12 weeks]
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Secondary ID(s)
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0733-271
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2008_021
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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