Long-Term, Open Label Safety Study of Atomoxetine Hydrochloride in Patients, 6 Years and Older With Attention-Deficit/Hyperactivity Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,553
- 试验地点
- 1
- 主要终点
- Change From Baseline to 5 Year Endpoint in Pulse
研究概览
简要总结
To learn about the safety and any side effects of atomoxetine when given to children and adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for about 5 years (long-term).
Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been interrupted or, atomoxetine experienced on a known stable dose.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be at least 6 years old but less than 18 years old when enrolled in first atomoxetine study
- •Must meet the study criteria for ADHD
- •Must be willing to have blood drawn and to complete other test required for this study
排除标准
- •allergic to more than 1 kind of medicine or have had multiple bad reactions to any drug
- •taking certain medicines that could interact with atomoxetine
- •plan to move too far away from a doctor participating in this study in the next 5 years
- •current or past history of any of the following: alcohol or drug abuse within the past 3 months, bipolar I or II disorder, high blood pressure, organic brain disease or seizures, psychosis, other disorders or conditions diagnosed by a doctor that might make you unsuitable to participate in this study
研究组 & 干预措施
Atomoxetine
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted with be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
干预措施: atomoxetine (Drug)
结局指标
主要结局
Change From Baseline to 5 Year Endpoint in Pulse
时间窗: baseline, 5 years
Change From Baseline to 5 Year Endpoint in Body Weight
时间窗: baseline, 5 years
Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study
时间窗: Baseline through 5 years
Vital signs were assesed categorically using the term high for BP, high and low for pulse and temperature, or decreased for weight. For BP, high was an increase to a value above the 95th percentile of the National Institute of Health (NIH) values. For pulse, high was an increase of at least 25 beats per minute to at least 110, and low was a decrease of at least 20 beats per minute to at most 65 beats per minute. For temperature, high was an increase of at least 1 to 37.7 and low was a decrease of at least 1.3 to at most 35.6. Decrease in weight was marked by a reduction of at least 3.5%.
Change From Baseline to 5 Year Endpoint in BP
时间窗: baseline, 5 years
Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
时间窗: baseline, 5 years
Patients were assessed for changes in weight, height, and BMI. BMI is an estimate of body fat based on body weight divided by height squared.
Change From Baseline to 5 Year Endpoint in Heart Rate
时间窗: baseline, 5 years
Patients were assessed for changes in heart rate using electrocardiogram.
Number of Participants With Abnormal Laboratory Analytes During the Study
时间窗: baseline through 5 years
Standard reference ranges from Covance Laboratories were used in the determination of abnormal high and low values based on age and gender, where appropriate. Aspartate aminotransferase (AST); serum glutamic oxaloacetic transaminase (SGOT); units/liter (U/L); alanine aminotransferase (ALT); serum glutamic pyruvic transaminase (SGPT); millimoles/liter (mmol/L); grams/liter (g/L); micromoles/liter (umol/L); millimoles/liter-iron (mmol/L-Fe); trillion/liter (TI/L)or 10\^12 units/liter; Giga/liter (GI/L)or 10\^9 units/liter; femtoliters (fL); urinalysis (UA)
Change From Baseline to 5 Year Endpoint in Height
时间窗: baseline, 5 years
Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)
时间窗: baseline through 5 years
QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula. QTdat is the QT interval using a data specific correction method for children.
Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)
时间窗: baseline, 5 years
Patients were assessed for changes in ECG. The RR interval is the time duration between two consecutive R waves of the ECG. The QRS interval is the beginning of Q to the end of the S wave. The QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula.QTdat is the QT interval using a data specific correction method for children.
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
时间窗: baseline through 5 years
QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula. QTdat is the QT interval using a data specific correction method for children. For Males: Normal is \<430 ms, Borderline is \>=430 ms and \<450 ms, Prolonged is \>=450 ms. For Females: Normal is \<450 ms, Borderline is \>=450 ms and \<470 ms, Prolonged is \>=470 ms.
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
时间窗: 1 year through 5 years
Tanner Stage: I: no pubic hair at all (prepubertal Dominic state) II: small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum (males) or on the labia majora (females) III: hair becomes more coarse and curly, and begins to extend laterally IV: adult-like hair quality, extending across pubis but sparing medial thighs V: hair extends to medial surface of the thighs Age Groups: 1. age\<11.0 (female) and age\<12 (male) 2. 11=\<age\<12 (female) or 12\<=age\<13 (male) 3. 12=\<age\<15 (female) or 13=\<age\<15 (male) 4. age\>=15 (female and male)
次要结局
- Change From Baseline to 5 Year Endpoint in the Stroop Word Color Test(baseline, 5 years)
- Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score(baseline, 5 years)
- Change From Baseline to 5 Year Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and Subscale Scores(baseline, 5 years)
- Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores(baseline, 5 years)