Trial · NCT00568685
Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT00568685, Phase 3, Completed, Eli Lilly and Company; results first posted 2009-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD). Trials, record NCT00568685. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00568685
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
- NCT number
- NCT00568685
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 153 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Atomoxetine Hydrochloride, Atomoxetine hydrochloride, Atomoxetine hydrochloride
- First posted
- 2007-12-06
- Last updated
- 2010-01-26
- Results first posted
- 2009-12-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Baseline, Day 42 | 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). |
| 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 | Baseline, Days 7, 14, 42 | Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). |
| 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 | Baseline, Days 7, 14, 42 | Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened) |
| Secondary | Adverse Events Leading to Discontinuation | Baseline to Day 42 | Adverse Events (Preferred Term) leading to discontinuation by decreasing frequency |
| Secondary | Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary | Baseline to Day 42 | Columbia Suicide-Severity Rating Scale (C-SSRS) captures occurrence, severity \& frequency of suicide-related thoughts \& behaviors, via questions designed to solicit information to determine if a suicide-related thought or behavior occurred. The C-SSRS is not scored; recorded incidents are counted. C-SSRS was only required if an adverse event was reported that the investigator suspected to represent a suicidal thought or behavior. If the C-SSR was completed at a visit, the Self-Harm Supplement was also required. If a self-harm event was reported, the Self-Harm Follow-Up form was also required. |
| Secondary | Heart Rate Change From Baseline to Day 42 Endpoint | Baseline, Day 42 | |
| Secondary | Temperature Change From Baseline to Day 42 Endpoint | Baseline, Day 42 | |
| Secondary | Blood Pressure Change From Baseline to Day 42 Endpoint | Baseline, Day 42 | |
| Secondary | Weight Change From Baseline to Day 42 Endpoint | Baseline, Day 42 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Baseline, Days 7, 14, 42 | ITT population; last observation carried forward (LOCF) | units on a scale | MEAN |
| 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 | Baseline, Days 7, 14, 42 | ITT population; LOCF | units on a scale | MEAN |
| SECONDARY | Adverse Events Leading to Discontinuation | Baseline to Day 42 | As-treated population | events | NUMBER |
| 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 | Baseline, Day 42 | Analysis included all randomized participants (intent-to-treat population) | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary | Baseline to Day 42 | As treated population | participants | NUMBER |
| SECONDARY | Heart Rate Change From Baseline to Day 42 Endpoint | Baseline, Day 42 | ITT population | beats per minute (bpm) | MEAN |
| SECONDARY | Temperature Change From Baseline to Day 42 Endpoint | Baseline, Day 42 | ITT population | degrees Celsius | MEAN |
| SECONDARY | Blood Pressure Change From Baseline to Day 42 Endpoint | Baseline, Day 42 | ITT population | mmHg | MEAN |
| SECONDARY | Weight Change From Baseline to Day 42 Endpoint | Baseline, Day 42 | ITT population | kilograms (kg) | MEAN |
Source ClinicalTrials.gov
Results by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Atomoxetine 0.2 mg/kg/Day | Day 7 | -0.24 | Standard Deviation 0.480 | units on a scale |
| 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 | Atomoxetine 0.5 mg/kg/Day | Day 7 | -0.53 | Standard Deviation 0.612 | units on a scale |
| 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 | Atomoxetine 1.2 mg/kg/Day | Day 7 | -0.30 | Standard Deviation -.036 | units on a scale |
| 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 | Atomoxetine 0.2 mg/kg/Day | Day 14 | -0.73 | Standard Deviation 0.736 | units on a scale |
| 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 | Atomoxetine 0.5 mg/kg/Day | Day 14 | -0.90 | Standard Deviation 0.918 | units on a scale |
| 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 | Atomoxetine 1.2 mg/kg/Day | Day 14 | -0.92 | Standard Deviation 0.786 | units on a scale |
| 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 | Atomoxetine 0.2 mg/kg/Day | Day 42 | -1.04 | Standard Deviation 0.729 | units on a scale |
| 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 | Atomoxetine 0.5 mg/kg/Day | Day 42 | -1.30 | Standard Deviation 1.121 | units on a scale |
| 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 | Atomoxetine 1.2 mg/kg/Day | Day 42 | -1.56 | Standard Deviation 1.090 | units on a scale |
| 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 | Atomoxetine 0.2 mg/kg/Day | LOCF Endpoint | -0.98 | Standard Deviation 0.750 | units on a scale |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atomoxetine 0.2 Milligrams Per Kilogram, Per Day (mg/kg/Day) | 51 | |
| Overall Study | STARTED | Atomoxetine 0.5 mg/kg/Day | 51 | |
| Overall Study | STARTED | Atomoxetine 1.2 mg/kg/Day | 51 | |
| Overall Study | COMPLETED | Atomoxetine 0.2 Milligrams Per Kilogram, Per Day (mg/kg/Day) | 41 | |
| Overall Study | COMPLETED | Atomoxetine 0.5 mg/kg/Day | 46 | |
| Overall Study | COMPLETED | Atomoxetine 1.2 mg/kg/Day | 46 | |
| Overall Study | NOT COMPLETED | Atomoxetine 0.2 Milligrams Per Kilogram, Per Day (mg/kg/Day) | 10 | |
| Overall Study | NOT COMPLETED | Atomoxetine 0.5 mg/kg/Day | 5 | |
| Overall Study | NOT COMPLETED | Atomoxetine 1.2 mg/kg/Day | 5 |
Source ClinicalTrials.gov
Adverse events33
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain upper | Gastrointestinal disorders | Atomoxetine 0.00-0.35 mg/kg/Day | 0 | 51 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Atomoxetine 0.36-0.85 mg/kg/Day | 5 | 54 | 5 |
| other | Abdominal pain upper | Gastrointestinal disorders | Atomoxetine >0.85 mg/kg/Day | 4 | 48 | 5 |
| other | Nausea | Gastrointestinal disorders | Atomoxetine 0.00-0.35 mg/kg/Day | 2 | 51 | 2 |
| other | Nausea | Gastrointestinal disorders | Atomoxetine 0.36-0.85 mg/kg/Day | 3 | 54 | 3 |
| other | Nausea | Gastrointestinal disorders | Atomoxetine >0.85 mg/kg/Day | 2 | 48 | 2 |
| other | Irritability | General disorders | Atomoxetine 0.00-0.35 mg/kg/Day | 2 | 51 | 2 |
| other | Irritability | General disorders | Atomoxetine 0.36-0.85 mg/kg/Day | 2 | 54 | 2 |
| other | Irritability | General disorders | Atomoxetine >0.85 mg/kg/Day | 4 | 48 | 5 |
| other | Nasopharyngitis | Infections and infestations | Atomoxetine 0.00-0.35 mg/kg/Day | 3 | 51 | 3 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atomoxetine 0.00-0.35 mg/kg/Day | ||
| Total, all-cause mortality | Atomoxetine 0.36-0.85 mg/kg/Day | ||
| Total, all-cause mortality | Atomoxetine >0.85 mg/kg/Day | ||
| Total, other adverse events | Atomoxetine 0.00-0.35 mg/kg/Day | 15 | 51 |
| Total, other adverse events | Atomoxetine 0.36-0.85 mg/kg/Day | 22 | 54 |
| Total, other adverse events | Atomoxetine >0.85 mg/kg/Day | 27 | 48 |
| Total, serious adverse events | Atomoxetine 0.00-0.35 mg/kg/Day | 0 | 51 |
| Total, serious adverse events | Atomoxetine 0.36-0.85 mg/kg/Day | 1 | 54 |
| Total, serious adverse events | Atomoxetine >0.85 mg/kg/Day | 1 | 48 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00568685
GET https://conductscience.org/api/trials/v1/NCT00568685/results?page=2