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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: |
NCT00054938 |
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Date of registration:
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13/02/2003 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Prevention of Atherosclerosis and Heart Disease in Patients With Systemic Lupus Erythematosis (SLE)
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Scientific title:
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A Randomized Controlled Trial of Strategies for the Prevention of Accelerated Atherosclerosis in Systemic Lupus Erythematosus - A Pilot Study |
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Date of first enrolment:
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March 2003 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00054938 |
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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: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Matthew H. Liang, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Brigham and Women's Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria
- SLE as defined by the 1997 American College of Rheumatology criteria
- Acceptable methods of contraception
Exclusion Criteria
- Participation in another experimental protocol for ASVD prevention
- Heavy alcohol consumption ( >= 3 drinks/day)
- Aspirin intolerance
- Certain medications, including coumadin, ACE inhibitors, potassium supplements,
potassium sparing diuretics, cyclosporine, and lithium
- Peptic ulcer disease within 6 months prior to study entry
- History of an intracranial bleed or brain tumor
- Bleeding diathesis
- History of allergy or sensitivity to ACE inhibitors
- Uncontrolled high blood pressure (180 mm Hg/110 mm Hg)
- Creatinine > 2.0 mg/dl
- Renal artery stenosis
- Pregnant or breastfeeding
- Abnormal liver function tests (ALT > 2 X upper limit of normal)
- History of a muscle disease, or baseline CPK > 500U/L or 2 X upper limit of normal
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lupus
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: Vitamins: B6, B12, and folate
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Behavioral: heart health educational program
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Drug: aspirin
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Drug: ramipril
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Drug: pravastatin
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Secondary ID(s)
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P60 AR47782 NIAMS-077
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P60AR047782
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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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