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

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 25 Jul 2022

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At a glance

Drugs Sapropterin (Primary)
Indications Phenylketonuria
Focus Therapeutic Use
Acronyms SPARK
Sponsors BioMarin Pharmaceutical; Merck KGaA

Most Recent Events

17 Aug 2017 Status changed from active, no longer recruiting to completed.
03 May 2017 This trial has been completed in Netherlands.
28 Mar 2017 This trial has been completed in Germany (End date:2017-02-17), as per European Clinical Trials Database record.

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