临床试验/NCT00641329

NCT00641329已完成3 期

Phase III Evaluation of the Safety and Efficacy of CLONICEL (Clonidine HCl Sustained Release) as Add-on to Psychostimulant Medication vs. Psychostimulant Medication Alone in Children and Adolescents With ADHD

Addrenex Pharmaceuticals, Inc.0 个研究点目标入组 198 人开始时间: 2008年2月最近更新: 2010年4月9日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Addrenex Pharmaceuticals, Inc.
入组人数: 198
主要终点: ADHDRS-IV Total Score

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine if CLONICEL (clonidine HCl sustained release) is a safe and effective add-on to psychostimulant therapy in children and adolescents with attention deficit hyperactivity disorder (ADHD).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 6 Years 至 17 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Age 6-17 years, inclusive
•Diagnosis of ADHD
•Currently on a stable psychostimulant regimen for ADHD
•Lack of adequate response to stable psychostimulant regimen
•Ability to swallow tablets

排除标准

•Clinically significant illnesses or abnormalities upon evaluation
•Conduct Disorder
•Intolerance to clonidine
•History of seizures or syncope

研究组 & 干预措施

1

Experimental

干预措施: CLONICEL (clonidine HCl sustained release) (Drug)

2

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

ADHDRS-IV Total Score

时间窗: Week 5

Treatment Emergent Adverse Events, Laboratory Tests, Vital Signs, and ECGs

时间窗: Throughout Treatment and Follow-up Period

次要结局

未报告次要终点

研究者

发起方

Addrenex Pharmaceuticals, Inc.

申办方类型

Industry

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