An Open-Label, Chronic Exposure Evaluation of the Safety of CLONICEL (Clonidine HCl Sustained Release) in the Treatment of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 303
- 主要终点
- Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])
研究概览
简要总结
The purpose of this 12-month, multi-center, open-label study is to evaluate the safety of CLONICEL (clonidine HCl sustained release) when administered chronically under regular clinical conditions either as monotherapy or in combination with stimulant therapy to children and adolescents with attention deficit hyperactivity disorder (ADHD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female subject who has completed either study CLON-301 or study CLON-302, or discontinued early for reasons other than adverse events necessitating discontinuation
- •Age between 6 and 17 years, inclusive
- •Diagnosis of attention deficit hyperactivity disorder of the hyperactive or combined inattentive/hyperactive subtypes according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) criteria
- •General good health as judged by the Principal Investigator
- •Body mass index (BMI) ≥ 5th percentile of the subject's age group according to the CDC growth chart. BMI is calculated using the formula: weight (kg) / [height (m)]2
- •Subject as well as parent/guardian able to sign informed assent or consent form
排除标准
- •If female of child-bearing potential, pregnant or lactating or does not agree to use a medically acceptable form of birth control, such as hormonal medication, double-barrier method, or intrauterine device
- •Presence of a clinically significant illness or abnormality on physical examination or clinical laboratory evaluations that, in the opinion of the investigator, would increase the safety risks from clonidine administration or interfere with the ability of the patient to take part in the study.
- •Presence of clinically significant abnormality on centrally interpreted electrocardiogram readings
- •History or presence of a concomitant psychiatric disorder requiring psychotropic medication or a severe concomitant axis I or axis II disorder that could interfere with study assessments in the judgment of the Principal Investigator
- •Presence of a disorder that would interfere with the absorption, metabolism, or excretion of clonidine
- •Presence of alcohol or drug abuse.
研究组 & 干预措施
Arm A
CLONICEL (Clonidine HCl sustained release)
干预措施: CLONICEL (Clonidine HCl sustained release) (Drug)
结局指标
主要结局
Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])
时间窗: 1 year
Safety assessments were performed at each study visit according to the time and events schedule. All safety analysis were based on safety population
Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett's (QTcB) at Week 4
时间窗: At baseline and at Week 4
Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12
时间窗: At baseline and at weeks 1, 2, 3, 4, and months 2, 3, 4, 5, 6, 9, and 12
Change From Baseline in Systolic Blood Pressure at Week 4
时间窗: At baseline and at Week 4
Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement
Change From Baseline in Body Temperature at Week 4
时间窗: At baseline and at Week 4
Temperature was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement
Change From Baseline in Heart Rate at Week 4
时间窗: At baseline and at Week 4
Heart rate was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement
Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4
时间窗: At baseline and at Week 4
Change From Baseline in Diastolic Blood Pressure at Week 4
时间窗: At baseline and at Week 4
Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement
次要结局
- Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12(At baseline, months 1, 2, 3, 4, 6, 9, and 12)
- Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12(At baseline, months 1, 2, 3, 4, 6, 9, and 12)
- Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12(At baseline, months 1, 2, 3, 4, 6, 9, and 12)