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A Phase 2 Randomized Open-label 2-Treatment 2-Sequence 2-Period Crossover PK Study to Compare Plasma Concentrations of BH4 in Subjects With Endothelial Dysfunction Following 14 Days of Treatment by 2 Regimens: 6R-BH4 With Vitamin C and 6R-BH4 Alone

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A Phase 2 Randomized Open-label 2-Treatment 2-Sequence 2-Period Crossover PK Study to Compare Plasma Concentrations of BH4 in Subjects With Endothelial Dysfunction Following 14 Days of Treatment by 2 Regimens: 6R-BH4 With Vitamin C and 6R-BH4 Alone

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 10 Nov 2021

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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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