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
Phase of Trial: Phase III
Latest Information Update: 20 Sep 2017
At a glance
- Drugs Sapropterin (Primary)
- Indications Phenylketonuria
- Focus Therapeutic Use
- Acronyms SPARK
- Sponsors BioMarin Pharmaceutical; Merck KGaA
- 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.