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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01211080 |
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Date of registration:
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28/09/2010 |
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Primary sponsor: |
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Public title:
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Off Label Use of Propranolol for Infancy Hemangiomas
PIHS |
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Scientific title:
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Open-label, Uncontrolled Study of the Off Label Use of Propranolol for Infancy Hemangiomas to Identify Side Effects |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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72 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01211080 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Germany
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Contacts
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Name:
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Benno M Ure, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hannover Medical School |
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Name:
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Carsten R Engelmann, 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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Hannover Medical School |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Infants with "problematic" true infantile hemangiomas (potentially disfiguring hemangiomas
in the face, functional threatening hemangiomas of hands, feet, genitalia)> 4 weeks and <
8 months of age.
Exclusion Criteria:
"Uncomplicated" Hemangiomas (trunk, extremities), infants with heart disease, known
arrhythmias, bronchoobstructive disease, known hypoglycaemia events.
Age minimum:
1 Month
Age maximum:
8 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hemangioma
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Intervention(s)
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Drug: Propranolol
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Primary Outcome(s)
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Cosmesis of the lesion and surrounding skin
[Time Frame: Completed 8 months of life]
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Side effects
[Time Frame: Completed 8th month of life]
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Secondary Outcome(s)
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hemangioma size
[Time Frame: completed 8 th month of life]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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