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MechanismDopamine reuptake inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date05 Dec 1955 |
评估盐酸哌甲酯缓释胶囊注意缺陷多动障碍患者中的疗效和安全性的安慰剂对照、双盲、多中心研究
[Translation] A placebo-controlled, double-blind, multicenter study to evaluate the efficacy and safety of methylphenidate hydrochloride extended-release capsules in patients with attention deficit hyperactivity disorder
主要目的:
根据4周稳定剂量治疗后ADHD-IV父母评定量表总评分相对基线期的变化,证明个体化滴定剂量的MPH HCl缓释胶囊 (Medikinet® retard)在治疗中国儿童和青少年(6至<18岁)ADHD患者方面相对于安慰剂的优效性。
次要目的:
研究Medikinet® retard对比安慰剂治疗中国儿童和青少年ADHD患者的安全性。
研究给予 10 mg、20 mg 或 30 mg Medikinet® retard 后,MPH HCl在中国儿童和青少年中的 PK。
[Translation] Primary Objective:
To demonstrate the superiority of individually titrated doses of MPH HCl extended-release capsules (Medikinet® retard) over placebo in the treatment of Chinese children and adolescents (6 to <18 years old) with ADHD based on the change from baseline in the ADHD-IV Parent Rating Scale total score after 4 weeks of stable dose treatment.
Secondary Objectives:
To investigate the safety of Medikinet® retard versus placebo in the treatment of Chinese children and adolescents with ADHD.
To investigate the PK of MPH HCl in Chinese children and adolescents after administration of 10 mg, 20 mg, or 30 mg Medikinet® retard.
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