| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00969618 | A Long Term Follow-Up Study for Asian Adult Patients With Attention Deficit Hyperactivity Disorder | PHASE3 | COMPLETED | 211 | — | — | Nov 1, 2009 | Jan 1, 2012 | Dec 12, 2012 | 12 | Japan |
| NCT00962104 | Atomoxetine to Treat Asian Adult Patients With Attention-Deficit/Hyperactivity Disorder | PHASE3 | COMPLETED | 391 | — | — | Aug 1, 2009 | Feb 1, 2011 | Sep 11, 2012 | 24 | Japan, South Korea +1 |
| NCT00700427 | A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) | PHASE3 | COMPLETED | 2,017 | — | — | Jun 1, 2008 | Oct 1, 2013 | Jun 26, 2014 | 56 | Austria, Belgium +10 |
| NCT00568685 | Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) | PHASE3 | COMPLETED | 153 | — | — | Nov 1, 2007 | Nov 1, 2008 | Jan 26, 2010 | 3 | South Korea |
| NCT00447278 | A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents | PHASE3 | COMPLETED | 399 | — | — | Mar 1, 2007 | Jul 1, 2009 | Apr 27, 2010 | 35 | Belgium, France +7 |
| NCT00191945 | Efficacy and Safety of Atomoxetine in Children With Recent Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD) | PHASE3 | COMPLETED | 151 | — | — | May 1, 2005 | Feb 1, 2008 | Feb 2, 2010 | 11 | Spain |
| NCT00191386 | Long-Term Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder (AD/HD) | PHASE3 | COMPLETED | 228 | — | — | May 1, 2005 | Aug 1, 2009 | Dec 28, 2010 | 24 | Japan |
| NCT00191542 | Atomoxetine vs Placebo in the Treatment of ADHD in Swedish Children and Adolescents | PHASE3 | COMPLETED | 100 | — | — | Mar 1, 2005 | Aug 1, 2006 | Oct 11, 2006 | 9 | Sweden |
| NCT00191737 | An Open-Label Study of Atomoxetine in Adolescents With Attention-Deficit/Hyperactivity Disorder | PHASE3 | COMPLETED | 147 | — | — | Oct 1, 2004 | Feb 1, 2006 | Jan 26, 2007 | 2 | Germany |
| NCT00192023 | An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD). | PHASE3 | COMPLETED | 139 | — | — | Oct 1, 2004 | May 1, 2008 | Jan 18, 2010 | 12 | Italy |
| NCT00191516 | An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder | PHASE3 | COMPLETED | 257 | — | — | Oct 1, 2004 | Feb 1, 2006 | Jan 26, 2007 | 1 | Germany |
| NCT00191659 | Study of Broader Efficacy of Atomoxetine in the Treatment of ADHD in Children/Adolescents | PHASE3 | COMPLETED | 200 | — | — | Jun 1, 2004 | Apr 1, 2006 | Mar 2, 2007 | 1 | United Kingdom |
| NCT00191880 | Open-Label Trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 Years With Attention Deficit/Hyperactivity Disorder | PHASE3 | COMPLETED | 100 | — | — | May 1, 2004 | Jun 1, 2006 | Aug 29, 2006 | 8 | Canada |
| NCT00485459 | Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD | PHASE3 | COMPLETED | 106 | — | — | Feb 1, 2004 | Nov 1, 2004 | Jun 13, 2007 | 1 | Taiwan |
| NCT00485550 | Comparison of Atomoxetine Plus Either Comparator or Placebo in Children With ADHD Who Haven't Responded to Stimulant Therapy | PHASE3 | COMPLETED | 14 | — | — | Jan 1, 2004 | Mar 1, 2005 | Jun 13, 2007 | 1 | United States |
| NCT00191698 | Comparison of Atomoxetine and Placebo in Children and Adolescents With ADHD and ODD | PHASE3 | COMPLETED | 226 | — | — | Dec 1, 2003 | Nov 1, 2007 | Oct 31, 2008 | 16 | Australia, Belgium +6 |
| NCT00486083 | Comparison Atomoxetine Hydrochloride and Comparator in Pediatric Outpatients With ADHD | PHASE3 | COMPLETED | 330 | — | — | Dec 1, 2003 | Oct 1, 2004 | Jun 13, 2007 | 3 | China, Mexico +1 |
| NCT00485407 | Guiding Dose Increases in Patients Incompletely Responsive to Usual Doses of Atomoxetine | PHASE3 | COMPLETED | 377 | — | — | Jul 1, 2003 | Jun 1, 2005 | Nov 1, 2007 | 2 | United States, Canada |
| NCT00190684 | Long-Term, Open Label Atomoxetine Study | PHASE3 | COMPLETED | 1,553 | — | — | Aug 1, 2000 | Oct 1, 2009 | Jan 17, 2011 | 100 | United States, Australia +12 |
| NCT00636818 | Atomoxetine Asian Study in Adult Subjects With Attention-Deficit/Hyperactivity Disorder (ADHD) | PHASE2 | COMPLETED | 45 | — | — | Mar 1, 2008 | Oct 1, 2008 | Nov 4, 2010 | 11 | China, South Korea +1 |
| NCT00530335 | Atomoxetine Phase 2 Study in Japanese Adult Patients With Attention Deficit/Hyperactivity Disorder (ADHD) | PHASE2 | COMPLETED | 45 | — | — | Sep 1, 2007 | Apr 1, 2008 | Jul 27, 2011 | 12 | Japan |
| NCT00191295 | Atomoxetine Versus Placebo in Children With Attention Deficit/Hyperactivity Disorder (ADHD) | PHASE2 | COMPLETED | 240 | — | — | Feb 1, 2005 | Sep 1, 2006 | Nov 6, 2007 | 24 | Japan |
| NCT00485628 | Safety Study in Outpatient Japanese Children With ADHD | PHASE2 | COMPLETED | 37 | — | — | Apr 1, 2003 | Oct 1, 2003 | Jun 13, 2007 | 1 | Japan |
| NCT01177943 | A Bioequivalence (BE) Study in Healthy Subjects | PHASE1 | COMPLETED | 42 | — | — | Aug 1, 2010 | Oct 1, 2010 | Oct 27, 2011 | 1 | Japan |
CAARS-Inv:SV is a scale that assesses symptom severity over past week. Total ADHD symptom score consisted of 18 items (sum of inattention \[9 items, range: 0-27\] and hyperactivity-impulsivity \[9 items, range: 0-27\] subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54. Higher scores indicate greater impairment.
Conners' Adult ADHD Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV); 30-item scale (3 subscales): inattention, hyperactivity/impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (not at all/never) to 3 (very much/very frequently). Total ADHD symptoms score (SS)=inattention+hyperactivity/impulsivity (range:0-54). Higher score=more impairment. Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Maintenance of response during the randomized withdrawal phase was a reduction of ≥30% in the baseline CAARS-Inv:SV Total ADHD SS and a CGI-ADHD-S score ≤3. Participants had to continuously meet the response criteria, except for 1 excursion after assessment at Week 24 through Week 37 and 1 other excursion after assessment at Week 37 through Week 49. Excursions were not permitted at 2 consecutive visits.
Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 none/never or rarely) to 3 (severe/very often). Total scores range from 0 (no symptoms) to 54 (highly symptomatic).
CHIP-CE PRF: parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total Scores range from 0 to 54.
Details on the actual adverse events are presented in the Reported Adverse Events Section.
Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9) and hyperactivity/impulsivity (items #11-#19). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 54.
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%.
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.
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.
Patients were assessed for changes in heart rate using electrocardiogram.
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.
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.
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)
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)
The definition of a study adverse event was any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.
The Cmax values are based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject.
The AUC (0-tlast) is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (tlast) and is based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject.
| Arm | Type | Description |
|---|---|---|
| Atomoxetine | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Atomoxetine 0.2 milligram per kilogram per day (mg/kg/day) | ACTIVE_COMPARATOR | - |
| Atomoxetine 0.5 mg/kg/day | ACTIVE_COMPARATOR | - |
| Atomoxetine 1.2 mg/kg/day | ACTIVE_COMPARATOR | - |
| OEST | ACTIVE_COMPARATOR | Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension |
| A | EXPERIMENTAL | Atomoxetine is administered at 1.2 mg/kg/day, PO for 8 weeks, followed by 1.2 or 2.4 mg/kg/day, PO for 4 weeks, open label administration can continue for up to one year |
| B | PLACEBO_COMPARATOR | Placebo is administered by mouth, daily for 8 weeks. After 8 weeks, those randomized to placebo may be titrated to 1.2 mg/kg/day atomoxetine for the remainder of the study up to one year |
| Atomoxetine Oral Solution | EXPERIMENTAL | - |
| Atomoxetine Capsule Formulation | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Atomoxetine | DRUG | 40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks |
| Placebo | DRUG | Taken by mouth, once daily for 10 weeks. |
| atomoxetine hydrochloride | DRUG | Oral 40-100 mg/day |
| Other standard therapy for ADHD | DRUG | Any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension |
| atomoxetine 0.5 mg/kg/day | DRUG | atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO) |
| atomoxetine 1.2 mg/kg/day | DRUG | atomoxetine 1.2 mg/kg/day QD, PO |
| atomoxetine 1.2-1.4 mg/kg/day | DRUG | atomoxetine 1.2 - 1.4 mg/kg/day QD, PO |
| Methylphenidate Hydrochloride | DRUG | - |
Inclusion Criteria: * Patients who have completed the B4Z-JE-LYEE study (NCT00962104) and signed the Informed Consent Document (ICD). * Patients must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture and examinations, re...