NCT00332189

Study of Phenoptin in Subjects With Phenylketonuria Who Participated in Protocols PKU-004 or PKU-006

A Phase 3b, Multicenter, Open-Label Extension Study of Phenoptin in Subjects With Phenylketonuria Who Participated in Protocols PKU-004 or PKU-006

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: BioMarin Pharmaceutical · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety of long-term treatment with Phenoptin in subjects with phenylketonuria (PKU) who participated in Phase 3 clinical studies with Phenoptin.

Conditions

• Phenylketonuria

Interventions

Type	Name	Description
DRUG	sapropterin dihydrochloride	5-20mg/kg/day orally, dose may be adjusted up or down as needed at the discretion of the investigator in increments of 5mg/kg/day.

Timeline

• Start date: 2006-07-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2006-06-01
• Last updated: 2012-11-16
• Results posted: 2012-11-16

Locations

14 sites across 1 country: United States