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Last Updated: August 9, 2020

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CLINICAL TRIALS PROFILE FOR PROPRANOLOL HYDROCHLORIDE

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505(b)(2) Clinical Trials for propranolol hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01512173 Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo Completed Pierre Fabre Dermatology Phase 2 2012-01-01 There is an unsatisfied medical need for a first-line treatment of localized uncomplicated proliferating Infantile Hemangioma with a good benefit/risk profile. Pierre Fabre Dermatologie has developed a new formulation of propranolol (V0400 GL 01A) which is a topical gel adapted to paediatric use. The objective of this study is to evaluate topical propranolol efficacy and safety in the management of localized hemangioma.
New Combination NCT02641314 Metronomic Treatment in Children and Adolescents With Recurrent or Progressive High Risk Neuroblastoma Recruiting University of Cologne Phase 2 2016-10-01 Neuroblastoma is the second most frequent cause for death from cancer in childhood. Already one year after diagnosis of recurrence from high risk neuroblastoma, 75% of the patients experience further progression. Metronomic therapy is targeting not only the tumor cell, but also the tumor supplying vasculature and the interactions between Tumor and immune cells. The toxicity is expected to be low due to the low (but continuous) dosing of drugs. The study investigates the tolerance and the efficacy of a new combination of five drugs consisting of propranolol (antiangiogenetic, anti-neuroblastic), Celecoxib (modulating immune response, ant-neuroblastic), cyclophosphamide (antiangiogenetic, anti-neuroblastic), etoposide (antiangiogenetic, anti-neuroblastic), and vinblastin (antiangiogenetic, anti-neuroblastic). Vinblastin is scheduled every 14 days intravenously, all other drugs are applied daily throughout 365 days (except etoposide for 4x3 weeks). The efficacies of each of the drugs have been demonstrated in vitro and in vivo in animal studies. All drugs have been used in children for other conditions. From those experiences low toxicities and a favorable Quality of life are expected.
New Combination NCT02897986 Study of a Propranolol (HEMANGIOL®) and Oral Metronomic Vinorelbine (NAVELBINE®) Combination for Children and Teenagers With Refractory/Relapsing Solid Tumors Not yet recruiting Assistance Publique Hopitaux De Marseille Phase 1 2017-01-01 Cancer remains the first cause of death due to disease in children and adolescents despite important progress and 70% of the survivors present sequelae. It is therefore mandatory to generate new and preferably less toxic treatment strategies relying on new anticancer agents, and/or new combinations or schedules of administered compounds. Metronomic chemotherapy (MC) consists in administrating low doses of anticancer agents on a daily/weekly basis. MC has been showed to be a safe and effective way to administer chemotherapy to obtain anti-cancer effects through anti-angiogenic and pro-imune effects. Drug repositioning consist in using non-anticancer drug for which anti-cancer properties have been unveiled. Propranolol is a non selective beta-blocker initially used to treat hypertension but recently its anticancer properties have been discovered. The place of Betablockers as anticancer agents is supported by both preclinical and epidemiologic data. The investigators have showed that the use of betablockers could sensitize breast cancer, angiosarcoma and neuroblastoma to chemotherapy in vitro and in vivo at least in part via an anti-angiogenic mechanism. There are currently 12 clinical trials evaluating prospectively their potential in adults with cancer but none in children so far. The Objective is to determine the Maximal Tolerated Dose (MTD) of a combination of oral metronomic vinorelbine and daily oral propranolol. This study is a phase I trial with a "rolling six" design and a dose escalation with thrice weekly oral vinorelbine only plus addition of daily oral propranolol after completion of the first cycle. PK analysis of vinorelbine and propranolol will be performed. Once the recommended dose of the combination established 4 extension cohorts of 9 patients will be added Potential biomarkers (such as beta-adrenergic receptors on the tumours, B-tubulin isotypes in the tumour) will also be evaluated. This will provide a well tolerated, all oral combination for patients with refractory/relapsing tumours. This combination could also be then proposed as a maintenance for instance in patients with rhabdomyosarcoma or neuroblastoma.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for propranolol hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000197 Propranolol for Treatment of Cocaine Addiction - 2 Completed University of Pennsylvania Phase 2 1987-01-01 The purpose of this study is to evaluate the safety and efficacy of propanolol in the early treatment of cocaine dependence.
NCT00000197 Propranolol for Treatment of Cocaine Addiction - 2 Completed National Institute on Drug Abuse (NIDA) Phase 2 1987-01-01 The purpose of this study is to evaluate the safety and efficacy of propanolol in the early treatment of cocaine dependence.
NCT00000492 Beta-Blocker Heart Attack Trial (BHAT) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1977-09-01 To determine whether the regular administration of the beta-blocker drug propranolol to people who had had at least one documented myocardial infarction would result in a significant reduction of mortality from all causes over the follow-up period. Eligible volunteer patients were recruited to participate in a double-blind clinical trial within 21 days after the onset of the acute event. One-half of the patients were randomly assigned to a beta-blocking drug (propranolol) and one-half to a placebo. The trial also evaluated the effect of propranolol on incidences of coronary heart disease mortality, sudden cardiac death, and nonfatal myocardial infarction plus coronary heart disease mortality in persons with documented previous myocardial infarction.
NCT00000493 Multicenter Investigation of Limitation of Infarct Size (MILIS) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1977-09-01 To assess the ability of two separate therapeutic interventions, propranolol and hyaluronidase, to limit the ultimate size of an acute myocardial infarction. A secondary objective was to assess the influence of these therapies upon ventricular function and morbidity following myocardial infarction.
NCT00007592 Hypertension Screening and Treatment Program Completed VA Office of Research and Development N/A 1989-06-01 Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for propranolol hydrochloride

Condition Name

Condition Name for propranolol hydrochloride
Intervention Trials
Portal Hypertension 12
Liver Cirrhosis 11
Healthy 10
Post-Traumatic Stress Disorder 9
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Condition MeSH

Condition MeSH for propranolol hydrochloride
Intervention Trials
Stress Disorders, Post-Traumatic 21
Stress Disorders, Traumatic 19
Hemangioma 18
Disease 17
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Clinical Trial Locations for propranolol hydrochloride

Trials by Country

Trials by Country for propranolol hydrochloride
Location Trials
United States 183
Canada 20
China 16
France 14
Taiwan 9
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Trials by US State

Trials by US State for propranolol hydrochloride
Location Trials
Texas 17
California 16
New York 15
Pennsylvania 11
Maryland 10
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Clinical Trial Progress for propranolol hydrochloride

Clinical Trial Phase

Clinical Trial Phase for propranolol hydrochloride
Clinical Trial Phase Trials
Phase 4 51
Phase 3 29
Phase 2/Phase 3 21
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Clinical Trial Status

Clinical Trial Status for propranolol hydrochloride
Clinical Trial Phase Trials
Completed 88
Recruiting 75
Not yet recruiting 37
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Clinical Trial Sponsors for propranolol hydrochloride

Sponsor Name

Sponsor Name for propranolol hydrochloride
Sponsor Trials
National Institute of Mental Health (NIMH) 7
National Institutes of Health (NIH) 7
Taipei Veterans General Hospital, Taiwan 6
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Sponsor Type

Sponsor Type for propranolol hydrochloride
Sponsor Trials
Other 306
Industry 40
NIH 39
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