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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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19 February 2015 |
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Main ID: |
NCT01322308 |
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Date of registration:
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23/03/2011 |
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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 Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus
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Scientific title:
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Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus, a Randomized, Double-blind, Placebo-controlled Clinical Trial |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01322308 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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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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Carlos Posadas, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Head of the Endocrinology Department |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Eligible participants were premenopausal women with SLE
- Older than 18 years
- Attending the outpatient Rheumatology Clinic at three Mexico City community tertiary
care hospitals
Exclusion Criteria:
- menopause
- diabetes
- thyroid dysfunction
- neurological
- hepatic
- renal or liver disease
- personal history of high blood pressure
- CHD (coronary heart disease)
- cerebrovascular events
- chronic or acute infections
- malignancy
- nor history of chronic drugs or alcohol abuse
- smoking
- pregnancy or breast-feeding
- intake of hormones or lipid-regulating drugs
Age minimum:
18 Years
Age maximum:
55 Years
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: pioglitazone
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Drug: placebo
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Primary Outcome(s)
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improvement of endothelial function
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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change in HDL particle physicochemical characteristics
[Time Frame: 12 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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