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Trial record 2 of 116 for:    Atenolol

Efficacy and Safety of Propranolol Versus Atenolol on the Proliferative Phase of Infantile Hemangioma

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ClinicalTrials.gov Identifier: NCT02342275
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Yi Ji, West China Hospital

Brief Summary:
The purpose of this study is to compare the efficacy of orally administered propranolol versus atenolol in the treatment of potentially disfiguring or functionally threatening IHs.

Condition or disease Intervention/treatment Phase
Hemangioma Drug: Propranolol Drug: Atenolol Phase 3

Detailed Description:

Currently, propranolol is the preferred treatment for problematic proliferating infantile hemangiomas (IHs). Although propranolol is clearly efficacious, rare side effects, such as hypoglycemia, may be life-threatening. The possibility of propranolol resistance and treatment failure is also important, and highlights the need for employing more established techniques in certain cases.

Nonselective β-adrenergic antagonists, such as propranolol and timolol, are competitive antagonists of catecholamines at the β1- and β2-adrenergic receptors (β-ARs). β2-AR blockade may result in hypoglycemia as a result of decreased glycogenolysis, gluconeogenesis, and lipolysis. Moreover, bronchial hyperreactivity is a direct effect of nonselective β-blockers, resulting in bronchospasms due to pulmonic β2-AR blockade. A solution to minimize many of the side effects of nonselective β-blocker therapy may be the use of more selective β1-blockers such as metoprolol or atenolol, which, at low dosages, have little β2 activity. Unfortunately, there is a paucity of clinical data comparing the efficacy of selective and non-selective β-blocker. Furthermore, because of the broad heterogeneity of IH (e.g., proliferating versus involuting), confounding with other pharmacologic exposures (e.g., corticosteroids), associated complications (e.g., ulceration) and comorbid medical anomalies (e.g., PHACE) that can influence efficiency after IH treatment, observational studies are unable to definitively establish the clinical utility of β-blockers in IH. Thus, questions regarding the efficacy of the subtypes of β-blockers must be answered in randomized controlled trials, which may provide the only way to overcome the selection and ascertainment bias.

The purpose of this study is to compare the efficacy of orally administered propranolol versus atenolol in the treatment of potentially disfiguring or functionally threatening IHs.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Propranolol Versus Atenolol on the Proliferative Phase of Infantile Hemangioma
Study Start Date : October 2013
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

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MedlinePlus related topics: Birthmarks

Arm Intervention/treatment
Active Comparator: Propranolol
Propranolol
Drug: Propranolol
Initiated at a dosage of 1 mg/kg per day divided 3 times daily for 1 week, and then increased to 2 mg/kg per day divided 3 times daily from weeks 2 to 24.
Other Name: Oral propranolol

Active Comparator: Atenolol
Atenolol
Drug: Atenolol
Initiated at a dosage of 0.5 mg/kg per day in a single dose for 1 week, and then increased to 1 mg/kg per day in a single dose from weeks 2 to 24.
Other Name: Oral atenolol




Primary Outcome Measures :
  1. The color (redness or blueness) and size of IH [ Time Frame: 24 weeks ]
    Response to therapy was measured by blinded volume estimation at weeks 0, 4, 8, 12, 16, 20, and 24 by using serial hemispheric measurements of tumor volume. Photographs of the IHs were taken at weeks 0, 1, 4, 12, and 24 by a medical photographer.


Secondary Outcome Measures :
  1. Frequency of adverse events (e.g. hypotension, hypoglycemia, sleep disturbance, cool or mottled extremities, diarrhea, etc.) collected by investigator and reported by parents. [ Time Frame: 24 weeks ]
  2. Cardiovascular examinations, including blood pressure, heart rate and electrocardiogram were performed at weeks 0, 1, 4, 12, and 24. [ Time Frame: 24 weeks ]
  3. Blood glucose was measured at weeks 0, 1, 4, 12, and 24. [ Time Frame: 24 weeks ]
  4. Neurodevelopment [ Time Frame: 12 months ]
    At one year of age, children were tested using the Gesell Developmental Schedules (GDS)

  5. Quality of life (QOL) [ Time Frame: 24 weeks ]
    The QOL instrument for IH (IH-QOL), Pediatric Quality of Life Inventory (PedsQLTM) 4.0 Genetic Core Infant Scales (GCIS), PedsQLTM 4.0 Family Impact Module (FIM) and PedsQLTM Family Information Form (FIF) were used.



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Ages Eligible for Study:   up to 24 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients younger than 24 weeks.
  • Presenting a hemangioma with the following characteristics:
  • Subcutaneous and/or cutaneous
  • Minimum diameter of 1.5 cm on face, 3 cm outside face and 1.5 cm if it is ulcerated.
  • Consent of both parents (or the person having parental authority in families)

Exclusion Criteria:

  • Infant presenting contraindications for the administration of propranolol or atenolol.
  • Hemangioma has been previous treated with corticosteroids, laser, cryotherapy, or only other treatments.
  • Patients with an inability to participate or to follow the study treatment and assessment plan.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342275


Locations
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China, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital
Investigators
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Principal Investigator: Yi Ji, MD, PhD West China Hospital

Publications:
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Responsible Party: Yi Ji, Doctor, West China Hospital
ClinicalTrials.gov Identifier: NCT02342275     History of Changes
Other Study ID Numbers: 2014-229
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yi Ji, West China Hospital:
Infantile hemangioma
Propranolol
Atenolol
Efficacy
Safety
Additional relevant MeSH terms:
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Atenolol
Hemangioma
Hemangioma, Capillary
Port-Wine Stain
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists