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

Trial Profile

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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 May 2017

At a glance

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

    • 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.
    • 09 Mar 2017 This trial has been completed in Italy, as per European Clinical Trials Database record.
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