Target Mean Arterial Blood Pressure 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

Target mean arterial pressure and time established during the open-label study drug period
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

开放标签试验药物阶段确定的目标平均动脉压及对应时长
试验描述
本研究为一项II期随机双盲安慰剂对照撤药试验，旨在评估硝普钠（sodium nitroprusside, SNP）在儿科受试者中的疗效、安全性与耐受性。研究目标为明确至少持续12小时的稳定输注方案下，硝普钠对血压的作用持久性，并评估在持续输注硝普钠至少12小时后临时暂停输注、进入30分钟盲法阶段时出现反跳性高血压的可能性。纳入对象为年龄小于17岁、需通过药物控制血压至少12小时的儿童受试者。