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sapropterin dihydrochloride

Study to Evaluate the Response to and Safety of an 8-Day Course of Phenoptin™ Treatment in Subjects With Phenylketonuria

Ensayo de BIOMARIN PHARMACEUTICAL INC en Phenylketonurias (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

700

previstos

Centros

13

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en dic 2004.

Qué mide

Evaluate the degree and frequency of response to Phenoptin™, as demonstrated by a reduction in blood Phe level among subjects with PKU who have elevated Phe levels (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective is to evaluate the degree and frequency of response to Phenoptin™ (sapropterin dihydrochloride), as demonstrated by a reduction in blood phenylalanine (Phe) level among subjects with phenylketonuria (PKU) who have elevated Phe levels. A secondary objective of this study is to evaluate the safety of Phenoptin™ treatment in this subject population, and identify individuals in this subject population who respond to Phenoptin™ treatment with a reduction in blood Phe level.

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Ficha completa en ClinicalTrials.gov (NCT00104260), actualizada en abr 2007.