[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] main purpose:
Individualized titrated doses of MPH HCl sustained-release capsules (Medikinet® retard) were demonstrated in the treatment of Chinese children and adolescents (6 to <18 years old) based on the change from baseline in the ADHD-IV Parental Rating Scale total score after 4 weeks of stable dose treatment. ) superiority over placebo in ADHD patients.
Secondary purpose:
To study the safety of Medikinet® retard versus placebo in Chinese children and adolescents with ADHD.
To study the PK of MPH HCl in Chinese children and adolescents following administration of 10 mg, 20 mg, or 30 mg Medikinet® retard.