Follow-Up Contact 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

Whether follow-up contact was made 30 days after discontinuation of study drug and any serious adverse event reported by participant
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

研究药物停药后30天内是否开展随访联络，以及受试者报告的任意严重不良事件。
研究描述
本研究为一项II期随机双盲安慰剂撤药对照试验，旨在评估硝普钠（sodium nitroprusside, SNP）在儿科受试者中的有效性、安全性与耐受性。研究目标包括确定持续至少12小时的稳定输注方案中，硝普钠对血压的作用持续时长，并评估在输注临时中断且已给予硝普钠至少12小时后的30分钟双盲阶段，反跳性高血压的发生风险。
纳入标准：年龄不足17岁、需接受药物性血压控制至少12小时的儿童。