NCT00104247

Study to Evaluate the Safety and Efficacy of Phenoptin™ in Subjects With Phenylketonuria Who Have Elevated Phenylalanine Levels

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Phenoptin™ in Subjects With Phenylketonuria Who Have Elevated Phenylalanine Levels

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: BioMarin Pharmaceutical · Industry
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of Phenoptin™ (sapropterin dihydrochloride) in reducing blood phenylalanine (Phe) levels in subjects with phenylketonuria.

Conditions

• Phenylketonurias

Interventions

Type	Name	Description
DRUG	sapropterin dihydrochloride, 6R-BH4, tetrahydrobiopterin

Timeline

• Start date: 2005-03-01
• Completion: 2006-02-01
• First posted: 2005-02-25
• Last updated: 2014-07-23
• Results posted: 2009-04-16

Locations

13 sites across 1 country: United States