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Clinical trial

A Phase IIIb, Multicentre, Open-Label, Randomized, Controlled Study of the Efficacy, Safety, and Population Pharmacokinetics of Sapropterin Dihydrochloride (Kuvan®) in Phenylketonuria (PKU) Patients <4 Years Old.

NCT01376908 is registered in ClinicalTrials.gov with BioMarin Pharmaceutical as lead sponsor.

NCT NCT01376908
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase IIIb, Multicentre, Open-Label, Randomized, Controlled Study of the Efficacy, Safety, and Population Pharmacokinetics of Sapropterin Dihydrochloride (Kuvan®) in Phenylketonuria (PKU) Patients <4 Years Old.
Lead sponsor
BioMarin Pharmaceutical
Phase
Phase 3
Overall status
Completed
Start date
June 30, 2011
Completion date
February 17, 2017
Enrollment
56 (actual)
Sites
22

Conditions

As the registry lists them; a condition with its own page is linked.

phenylketonuria