Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104247
Status:
COMPLETED
Last Update Posted:
2014-07-23
First Post:
2005-02-24
Brief Title:
Study to Evaluate the Safety and Efficacy of Phenoptin in Subjects With Phenylketonuria Who Have Elevated Phenylalanine Levels
Sponsor:
BioMarin Pharmaceutical
Organization:
BioMarin Pharmaceutical
Study Overview
Official Title:
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
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None