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Completed Phase 2Phase 3 Interventional Results available

Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy

ClinicalTrials.gov ID: NCT01056341

Public ClinicalTrials.gov record NCT01056341. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 8:55 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomised, Controlled, Multidose, Multicentre, Adaptive Phase II/III Study in Infants With Proliferating Infantile Hemangiomas (IHs) Requiring Systemic Therapy to Compare 4 Regimens of Propranolol (1 or 3 mg/kg/Day for 3 or 6 Months) to Placebo (Double Blind).

Study identification

NCT ID
NCT01056341
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Pierre Fabre Dermatology
Industry
Enrollment
512 participants

Conditions and interventions

Interventions

  • Propranolol Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
35 Days to 150 Days
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2009
Primary completion
Apr 30, 2012
Completion
Oct 31, 2013
Last update posted
Dec 9, 2015

2010 – 2013

United States locations

U.S. sites
10
U.S. states
8
U.S. cities
10
Facility City State ZIP Site status
University of California Irvine California 92697-1385
Lucile Packard Children's Hospital Redwood City California 94063-5334
Rady Children's Hospital San Diego California 92123
Miami Children's Hospital Miami Florida 33155
Children's Memorial Hospital Chicago Illinois 60614
Cardinal Glennon Children's Hospital St Louis Missouri 63104
State University of NY Brooklyn New York 11203
Oregon Health Sciences University Portland Oregon 97239
Dell Children's Medical center Austin Texas 78723
Seattle Children's Hospital Seattle Washington 98105

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 49 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01056341, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 9, 2015 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01056341 live on ClinicalTrials.gov.

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