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.