CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 111 enrolled
Drug / intervention
sapropterin dihydrochloridedrug
Likely dose
sapropterin dihydrochloride 20mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00332189
NCT00332189Phase 3Completed
CompareCT.gov

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

BioMarin Pharmaceutical·interventional·Posted Jun 1, 2006·Updated Nov 16, 2012

In Brief

A Phase 3 clinical trial evaluating sapropterin dihydrochloride for Phenylketonuria. Completed, enrolled 111 participants across 14 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhenylketonuria
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 1, 2006
Enrollment StartJul 1, 2006
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 20.1 years ago

Interventions

sapropterin dihydrochloridedrug

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.