Response to Kuvan® in Subjects With Phenylketonuria (PKU) in a 4 Weeks Testing Period
Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to evaluate the proportion of responders (that is,
greater than or equal to [>=] 30 percent reduction from Baseline in blood phenylalanine [Phe]
level) to treatment with Kuvan® (sapropterin dihydrochloride) 20 milligram per kilogram per
day (mg/kg/day) for 28 days.
Phase:
Phase 4
Details
Lead Sponsor:
Merck KGaA Merck KGaA, Darmstadt, Germany
Collaborators:
Merck Serono Norway Smerud Medical Research International AS