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Vital Signs Dataset in 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

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https://dash.nichd.nih.gov/dataset/968
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Height/length and weight, vital signs including pulse, blood pressure, and mean arterial pressure taken during open label and blinded study drug periods, and pulse and blood pressure within 30 minutes of discontinuation of blinded study drug Study Description 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. Children less than 17 years of age who require pharmacologic blood pressure control for at least 12 hours
创建时间:
2015-06-19
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