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.

Trial Profile

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.

Completed
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
  • Most Recent Events

    • 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.
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