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Clinical trial

Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus

ID
Name
0733-271
Description
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 arms
Trial start
2007-09-19
Estimated PCD
2008-02-01
Trial end
2008-02-01
Status
Terminated
Phase
Early phase I
Treatment
simvastatin
simvastatin 20mg daily at nights for 12 weeks. Tablets
Arms:
1
Other names:
Zocor, MK0733
Comparator: Placebo
placebo daily at nights for 12 weeks. Tablets
Arms:
2
Size
4
Primary endpoint
Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.
Baseline and 12 weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 4, 'type': 'ACTUAL'}}
Updated at
2024-05-23

1 organization

2 products

1 indication

Organization
Organon and Co
Product
simvastatin
Indication
Systemic Lupus Erythematosus
Product
Comparator