NCT01732471View on ClinicalTrials.gov

Phase 3 Open-label Study to Evaluate the Response and Safety of Kuvan® in Subjects With Phenylketonuria

PHASE3CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

Conditions
Phenylketonuria
Interventions
DRUG

Kuvan®

Kuvan® (sapropterin dihydrochloride) will be administered orally at a dose of 20 milligram per kilogram per day (mg/kg/day) once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment will be continued at the same dose for further 6 weeks.

Trial Locations (1)

Unknown

Please contact Merck KGaA Communication Center, Darmstadt

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT01732471 - Phase 3 Open-label Study to Evaluate the Response and Safety of Kuvan® in Subjects With Phenylketonuria | Biotech Hunter | Biotech Hunter