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Last Updated: January 25, 2022

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CLINICAL TRIALS PROFILE FOR SAPROPTERIN DIHYDROCHLORIDE

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All Clinical Trials for Sapropterin Dihydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00104247 ↗ Study to Evaluate the Safety and Efficacy of Phenoptin™ in Subjects With Phenylketonuria Who Have Elevated Phenylalanine Levels Completed BioMarin Pharmaceutical Phase 3 2005-03-01 The primary objective of this study is to evaluate the efficacy of Phenoptin™ (sapropterin dihydrochloride) in reducing blood phenylalanine (Phe) levels in subjects with phenylketonuria.
NCT00104260 ↗ Study to Evaluate the Response to and Safety of an 8-Day Course of Phenoptin™ Treatment in Subjects With Phenylketonuria Completed BioMarin Pharmaceutical Phase 2 2004-12-01 The primary objective is to evaluate the degree and frequency of response to Phenoptin™ (sapropterin dihydrochloride), as demonstrated by a reduction in blood phenylalanine (Phe) level among subjects with phenylketonuria (PKU) who have elevated Phe levels. A secondary objective of this study is to evaluate the safety of Phenoptin™ treatment in this subject population, and identify individuals in this subject population who respond to Phenoptin™ treatment with a reduction in blood Phe level.
NCT00325962 ↗ A Study of the Effects of 6R-BH4 on Blood Pressure in Subjects With Poorly Controlled Systemic Hypertension Completed BioMarin Pharmaceutical Phase 2 2006-05-01 The purpose of this study is to determine whether 6R-BH4 (sapropterin dihydrochloride) is safe and effective in the treatment of poorly controlled hypertension in the presence or absence of type 2 diabetes.
NCT00403494 ↗ A Phase 2 Study of the Effects of Sapropterin Dihydrochloride on Symptomatic Peripheral Arterial Disease Completed BioMarin Pharmaceutical Phase 2 2006-12-01 The purpose of this study is to evaluate whether sapropterin dihydrochloride is safe and effective in the treatment of intermittent claudication (IC) caused by peripheral arterial disease (PAD).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sapropterin Dihydrochloride

Condition Name

Condition Name for Sapropterin Dihydrochloride
Intervention Trials
Phenylketonuria 17
Autistic Disorder 2
Phenylketonurias 2
Radiation-Induced Dermatitis 1
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Condition MeSH

Condition MeSH for Sapropterin Dihydrochloride
Intervention Trials
Phenylketonurias 20
Hypertension 3
Intermittent Claudication 2
Disease 2
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Clinical Trial Locations for Sapropterin Dihydrochloride

Trials by Country

Trials by Country for Sapropterin Dihydrochloride
Location Trials
United States 119
Canada 6
Italy 3
Germany 3
Spain 3
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Trials by US State

Trials by US State for Sapropterin Dihydrochloride
Location Trials
California 10
Texas 8
Pennsylvania 7
Missouri 6
Massachusetts 6
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Clinical Trial Progress for Sapropterin Dihydrochloride

Clinical Trial Phase

Clinical Trial Phase for Sapropterin Dihydrochloride
Clinical Trial Phase Trials
Phase 4 2
Phase 3 4
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Sapropterin Dihydrochloride
Clinical Trial Phase Trials
Completed 25
Terminated 4
Not yet recruiting 2
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Clinical Trial Sponsors for Sapropterin Dihydrochloride

Sponsor Name

Sponsor Name for Sapropterin Dihydrochloride
Sponsor Trials
BioMarin Pharmaceutical 24
University of Missouri-Columbia 3
Merck KGaA 3
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Sponsor Type

Sponsor Type for Sapropterin Dihydrochloride
Sponsor Trials
Other 35
Industry 30
NIH 2
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Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
Express Scripts
McKesson
Johnson and Johnson
Merck

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