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.
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.
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.
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).
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