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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: |
NCT01217125 |
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Date of registration:
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06/10/2010 |
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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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Rapamycin In Angiomyolipomas In Patients With Tuberous Sclerosis
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Scientific title:
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CLINICAL TRIAL TO DETERMINE THE EFFICACY AND SAFETY OF RAPAMYCIN IN ANGIOMYOLIPOMAS IN PATIENTS WITH TUBEROUS SCLEROSIS |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01217125 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, 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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Roser Torra, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fundacio Puigvert, Barcelona |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Diagnosis of tuberousclerosis Angiomyolipoma >2cm age>10 years
Exclusion Criteria:
Creatinine >4 No recent AML bleeding No hepatic abnormalities (liver tests 2fold)
Hematocrit<27% Thrombocytopenia (<100.000/mm3) Leukopenia (<3000/mm3) Ischemic cardiopathy
Recent surgery (2 months prior to enrollment) Pregnancy Serum cholesterol over 7.8 mmol/l
or hypertriglyceridemia fasten(>4.6 mmol/l) non controlled with drugs malignancy in the
previous 2 years allergy to macrolides
Age minimum:
10 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Angiomyolipoma
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Intervention(s)
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Drug: Sirolimus
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Primary Outcome(s)
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Angiomyolipoma volume
[Time Frame: 2 years]
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Secondary Outcome(s)
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skin lesions, AML complications,
[Time Frame: 2 years]
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Secondary ID(s)
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EudraCT 2007-005978-30
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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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