NCT00532844 - A Phase 2, Pharmacokinetic (PK) Study of 6R-BH4 Alone or 6R-BH4 With Vitamin C in Subjects With Endothelial Dysfunction | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

November 30, 2008

Study Completion Date

March 31, 2009

Conditions

Endothelial Dysfunction

Interventions

DRUG

Sapropterin Dihydrochloride

Sapropterin Dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 and Day 28.

DRUG

Sapropterin Dihydrochloride and Vitamin C

Sapropterin Dihydrochloride 5 mg/kg and 500 mg Vitamin C twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 and Day 28.

Trial Locations (1)

Unknown

Hackensack