Phase 3 Open-label Study to Evaluate the Response and Safety of Kuvan® in Subjects With Phenylketonuria
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
This is an open-label, non-comparative, Phase 3 study to evaluate the degree, frequency of
response and safety of Kuvan® (sapropterin dihydrochloride) in subjects aged 4 to 18 years
who have phenylketonuria and with elevated blood phenylalanine level of greater than or equal
to 450 micromole per liter.