A Phase 2, Randomized, Open-label, 2-Treatment, 2-Sequence, 2-Period Crossover, Pharmacokinetic (PK) Study to Compare the Plasma Concentrations of BH4 in Subjects With Endothelial Dysfunction Following 14 Days of Treatment by Each of 2 Regimens: 6R-BH4 With Vitamin C and 6R-BH4 Alone.
Phase of Trial: Phase II
Latest Information Update: 31 Dec 2014
At a glance
- Drugs Sapropterin (Primary) ; Ascorbic acid
- Indications Essential hypertension
- Focus Pharmacokinetics
- Sponsors BioMarin Pharmaceutical
- 01 May 2009 NCT has reported additional lead trial investigator and actual patient number as 52.
- 01 May 2009 Actual end date (Mar 2009) added as reported by ClinicalTrials.gov.
- 01 May 2009 Status changed from recruiting to completed as reported by ClinicalTrials.gov.