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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR SAPROPTERIN DIHYDROCHLORIDE

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Clinical Trials for Sapropterin Dihydrochloride

Trial ID Title Status Sponsor Phase 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 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 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 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 6R-BH4 on Symptomatic Peripheral Arterial Disease Completed BioMarin Pharmaceutical Phase 2 The purpose of this study is to evaluate whether 6R-BH4 (sapropterin dihydrochloride) is safe and effective in the treatment of intermittent claudication (IC) caused by peripheral arterial disease (PAD).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Sapropterin Dihydrochloride

Condition Name

Condition Name for Sapropterin Dihydrochloride
Intervention Trials
Phenylketonuria 16
Autistic Disorder 2
Phenylketonurias 2
Schizophrenia 1
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Condition MeSH

Condition MeSH for Sapropterin Dihydrochloride
Intervention Trials
Phenylketonurias 20
Hypertension 3
Autistic Disorder 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 108
Canada 6
Germany 4
Spain 3
Italy 3
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Trials by US State

Trials by US State for Sapropterin Dihydrochloride
Location Trials
California 10
Texas 7
Pennsylvania 6
Wisconsin 5
Utah 5
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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 17
Terminated 3
Unknown status 3
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Clinical Trial Sponsors for Sapropterin Dihydrochloride

Sponsor Name

Sponsor Name for Sapropterin Dihydrochloride
Sponsor Trials
BioMarin Pharmaceutical 19
Merck KGaA 3
The Children's Health Council 2
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Sponsor Type

Sponsor Type for Sapropterin Dihydrochloride
Sponsor Trials
Industry 24
Other 24
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Mallinckrodt
Deloitte
McKesson
UBS
Merck
QuintilesIMS
Johnson and Johnson
Chinese Patent Office

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