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A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Pharmacodynamics of Sodium Nitroprusside During Prolonged Infusion in Pediatric Subjects

Book Chapter

Authors:
Hammer, G. ; Schulman, S.; Drover, D. ; Anand, R.; Lewandowski, A.

Secondary:
Best Pharmaceuticals for Children Act (BPCA) Clinical Reports

Location:
Bethesda, MD

PMID:
36516282

URL:
https://www.ncbi.nlm.nih.gov/pubmed/36516282

Keywords:
sodium nitroprusside pediatric

Abstract:
A Phase II, randomized, double-blind, withdrawal to placebo study examining the efficacy, safety, and tolerability of sodium nitroprusside (SNP) in pediatric subjects. Objectives were to determine the persistence of the effect of SNP on blood pressure during stable infusion regimens lasting at least 12 hours and to assess the potential for rebound hypertension during a 30 minute blinded phase following administration of SNP for at least 12 hours when infusion is temporarily discontinued.

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