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Generated: February 20, 2019

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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).
NCT00435331 6R-BH4 Pulmonary Arterial Hypertension Study Completed BioMarin Pharmaceutical Phase 1 The purpose of this study is to determine whether the addition of sapropterin dihydrochloride (6R-BH4) to existing treatment has any effect in patients with pulmonary arterial hypertension (PAH). Patients with PAH have low levels of a substance called nitric oxide (NO). Tetrahydrobiopterin (BH4) is a substance produced by the body that is an essential requirement in the formation of NO. NO is thought to be helpful in keeping blood vessels in the lung healthy. 6R-BH4 is an experimental (unproven) medicine made in the lab that is very much like the BH4 that our own body makes. The researchers are investigating whether 6R-BH4 can be added safely to current treatment for PAH and whether there is any evidence of benefit from its use. The study will take approximately one year to complete from the time recruitment begins. The primary objective of the study is to evaluate the safety of oral 6R-BH4, administered in escalating doses in addition to standard care, in subjects with pulmonary arterial hypertension (PAH). The secondary objective of the study is to evaluate change in biochemical markers of endothelial dysfunction and nitric oxide synthetase activity (coupled and uncoupled) in subjects with PAH receiving escalating doses of oral 6R-BH4 in addition to standard care. The third objective of the study is to evaluate change in biomarkers of disease progression, 6-minute walk (6MW) distance, Borg dyspnea scores, and quality of life (QOL) measures in subjects with PAH receiving escalating doses of oral 6R-BH4 in addition to standard care.
NCT00435331 6R-BH4 Pulmonary Arterial Hypertension Study Completed National Institutes of Health (NIH) Phase 1 The purpose of this study is to determine whether the addition of sapropterin dihydrochloride (6R-BH4) to existing treatment has any effect in patients with pulmonary arterial hypertension (PAH). Patients with PAH have low levels of a substance called nitric oxide (NO). Tetrahydrobiopterin (BH4) is a substance produced by the body that is an essential requirement in the formation of NO. NO is thought to be helpful in keeping blood vessels in the lung healthy. 6R-BH4 is an experimental (unproven) medicine made in the lab that is very much like the BH4 that our own body makes. The researchers are investigating whether 6R-BH4 can be added safely to current treatment for PAH and whether there is any evidence of benefit from its use. The study will take approximately one year to complete from the time recruitment begins. The primary objective of the study is to evaluate the safety of oral 6R-BH4, administered in escalating doses in addition to standard care, in subjects with pulmonary arterial hypertension (PAH). The secondary objective of the study is to evaluate change in biochemical markers of endothelial dysfunction and nitric oxide synthetase activity (coupled and uncoupled) in subjects with PAH receiving escalating doses of oral 6R-BH4 in addition to standard care. The third objective of the study is to evaluate change in biomarkers of disease progression, 6-minute walk (6MW) distance, Borg dyspnea scores, and quality of life (QOL) measures in subjects with PAH receiving escalating doses of oral 6R-BH4 in addition to standard care.
NCT00435331 6R-BH4 Pulmonary Arterial Hypertension Study Completed Vanderbilt University Medical Center Phase 1 The purpose of this study is to determine whether the addition of sapropterin dihydrochloride (6R-BH4) to existing treatment has any effect in patients with pulmonary arterial hypertension (PAH). Patients with PAH have low levels of a substance called nitric oxide (NO). Tetrahydrobiopterin (BH4) is a substance produced by the body that is an essential requirement in the formation of NO. NO is thought to be helpful in keeping blood vessels in the lung healthy. 6R-BH4 is an experimental (unproven) medicine made in the lab that is very much like the BH4 that our own body makes. The researchers are investigating whether 6R-BH4 can be added safely to current treatment for PAH and whether there is any evidence of benefit from its use. The study will take approximately one year to complete from the time recruitment begins. The primary objective of the study is to evaluate the safety of oral 6R-BH4, administered in escalating doses in addition to standard care, in subjects with pulmonary arterial hypertension (PAH). The secondary objective of the study is to evaluate change in biochemical markers of endothelial dysfunction and nitric oxide synthetase activity (coupled and uncoupled) in subjects with PAH receiving escalating doses of oral 6R-BH4 in addition to standard care. The third objective of the study is to evaluate change in biomarkers of disease progression, 6-minute walk (6MW) distance, Borg dyspnea scores, and quality of life (QOL) measures in subjects with PAH receiving escalating doses of oral 6R-BH4 in addition to standard care.
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
Phenylketonurias 2
Autistic Disorder 2
Liver Cirrhosis 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:

Fish and Richardson
Moodys
US Army
Covington
QuintilesIMS
Deloitte
Julphar
Merck
AstraZeneca

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