Phase 3
Completed N=153
Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT00568685 ↗Enrolled (actual)
153
Serious AEs
1.3%
Results posted
Dec 2009
Primary outcomePrimary: Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score — -9.55; -12.31; -14.51 units on a scale — p=0.0240
Summary
The purpose of this study is to provide information regarding the relative effectiveness of three different atomoxetine doses in the treatment of Korean children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score |
-9.55; -12.31; -14.51 | 0.0240 sig |
| SECONDARY Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint |
-0.24; -0.53; -0.30; -0.73; -0.90; -0.92 | 0.0048 sig |
| SECONDARY Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint |
3.57; 3.22; 3.54; 3.25; 3.20; 2.98 | 0.0153 sig |
| SECONDARY Adverse Events Leading to Discontinuation |
0; 1; 0; 0; 1; 0 | .4500 |
| SECONDARY Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary |
0; 0; 0 | — |
| SECONDARY Heart Rate Change From Baseline to Day 42 Endpoint |
87.86; 85.78; 90.10; 90.43; 90.35; 93.89 | 0.8005 |
| SECONDARY Temperature Change From Baseline to Day 42 Endpoint |
36.63; 36.56; 36.50; 36.58; 36.55; 36.59 | 0.4128 |
| SECONDARY Blood Pressure Change From Baseline to Day 42 Endpoint |
105.98; 102.49; 106.12; 107.82; 104.98; 108.48 | 0.9761 |
| SECONDARY Weight Change From Baseline to Day 42 Endpoint |
35.67; 35.54; 35.48; 36.10; 35.72; 36.39 | 0.2213 |
Eligibility Criteria
Inclusion Criteria
- Patients will be outpatients who are aged 6 to 18 years old at the initial screening visit.
- Patients must have ADHD, based on the accepted criteria for that disease
- Patients must not have taken any medication used to treat ADHD for at least two weeks prior to beginning study treatment; and at least one week prior to the study screening visit during which initial ADHD assessments were made
- Patients must be able to swallow capsules
- Patients and parents (or legal guardians) must be judged by the study investigator to be reliable to keep appointments for clinic visits and all tests, including blood tests and any other required examinations
Exclusion Criteria
- Patients must not have received any treatment within the last 30 days with a drug that has not been approved by their country's appropriate government agency
- Patients will not be included in the study if they have previously experienced any unwanted effects or serious medical events during atomoxetine treatment
- Patients will not be included in the study if they are judged by the study investigator to be at serious suicidal risk
- Patients will not be included in the study if they have cardiovascular disease or other conditions that could be worsened by an increased heart rate or increased blood pressure
Data sourced from ClinicalTrials.gov (NCT00568685). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.