Trial · NCT00191386
Long-Term Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder (AD/HD)
NCT00191386, Phase 3, Completed, Eli Lilly and Company; results first posted 2010-11-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-Term Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder (AD/HD). Trials, record NCT00191386. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00191386
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder (AD/HD)
- NCT number
- NCT00191386
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 228 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Atomoxetine hydrochloride
- First posted
- 2005-09-19
- Last updated
- 2010-12-28
- Results first posted
- 2010-11-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events for Long Term Safety and Tolerability | Baseline through 4 years | Details on the actual adverse events are presented in the Reported Adverse Events Section. |
| Secondary | Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score | Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years | Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) 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. |
| Secondary | Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S) | Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years | Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). |
| Secondary | Cytochrome P450 2D6 (CYP2D6) Phenotype Status | Over 1 year | Participants were categorized as either extensive metabolizers (EM) or poor metabolizers (PM). CYP2D6 is the primary atomoxetine metabolizing enzyme. The CYP2D6 genotype were analysed by testing the \*2, \*3, \*4, \*5, \*6, \*7, \*8, and \*10 alleles. Metabolizer status was determined by focusing on the normal(wild type, \*2), decreased(\*10), and defective allele(\*3, \*4, \*5, \*6, \*7, or \*8). PM were assigned to the patients had two defective alleles in any combination of \*3, \*4, \*5, \*6, \*7, or \*8 alleles. EM was all except for PM. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events for Long Term Safety and Tolerability | Baseline through 4 years | All patients who took at least one dose of study medication were included in the analyses of safety data. | Participants | NUMBER |
| SECONDARY | Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score | Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years | Full Analysis Set: Participants who met Study LYBC criteria, took 1 dose of drug, had a baseline/post-baseline measurement. Changes from baseline used LOCF approach. Baseline was the last non-missing measurement before taking atomoxetine (either LYDA Week 0 or LYBC Week 2). Endpoint was the last non-missing measurement in each assessment period. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S) | Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years | Full Analysis Set: Participants who met Study LYBC criteria, took 1 dose of drug, had a baseline/post-baseline measurement. Changes from baseline used LOCF approach. Baseline was the last non-missing measurement before taking atomoxetine (either LYDA Week 0 or LYBC Week 2). Endpoint was the last non-missing measurement in each assessment period. | Units on a scale | MEAN |
| SECONDARY | Cytochrome P450 2D6 (CYP2D6) Phenotype Status | Over 1 year | Full Analysis Set: Participants who met Study LYBC criteria, took 1 dose of drug, had a baseline/post-baseline measurement. Changes from baseline used LOCF approach. Baseline was the last non-missing measurement before taking atomoxetine (either LYDA Week 0 or LYBC Week 2). Endpoint was the last non-missing measurement in each assessment period. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events for Long Term Safety and Tolerability | Atomoxetine | Serious Adverse Events | 6 | Participants | |
| Number of Participants With Adverse Events for Long Term Safety and Tolerability | Atomoxetine | All Other Nonserious Adverse Events | 222 | Participants | |
Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score | Atomoxetine | Total Score 6 Months (n=228) | -14.1 | Standard Deviation 9.3 | Units on a scale |
Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score | Atomoxetine | Total Score 12 Months (n=178) | -16.0 | Standard Deviation 9.2 | Units on a scale |
Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score | Atomoxetine | Total Score 2 Years (n=143) | -17.7 | Standard Deviation 9.4 | Units on a scale |
Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score | Atomoxetine | Total Score 3 Years (n=105) | -20.0 | Standard Deviation 9.2 | Units on a scale |
Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score | Atomoxetine | Total Score 4 Years (n=62) | -20.1 | Standard Deviation 10.5 | Units on a scale |
| Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S) | Atomoxetine | 6 Months | -1.1 | Standard Deviation 1.1 | Units on a scale |
| Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S) | Atomoxetine | 12 Months | -1.3 | Standard Deviation 1.1 | Units on a scale |
| Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S) | Atomoxetine | 2 Years | -1.4 | Standard Deviation 1.0 | Units on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atomoxetine | 228 | |
| Overall Study | 6 Months | Atomoxetine | 183 | |
| Overall Study | 12 Months | Atomoxetine | 149 | |
| Overall Study | 2 Years | Atomoxetine | 105 | |
| Overall Study | 3 Years | Atomoxetine | 65 | |
| Overall Study | COMPLETED | Atomoxetine | 68 | |
| Overall Study | NOT COMPLETED | Atomoxetine | 160 |
Source ClinicalTrials.gov
Adverse events44
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 | Conjunctivitis allergic | Eye disorders | Atomoxetine | 13 | 228 | 17 |
| other | Myopia | Eye disorders | Atomoxetine | 12 | 228 | 13 |
| other | Abdominal pain | Gastrointestinal disorders | Atomoxetine | 53 | 228 | 106 |
| other | Constipation | Gastrointestinal disorders | Atomoxetine | 17 | 228 | 25 |
| other | Dental caries | Gastrointestinal disorders | Atomoxetine | 23 | 228 | 24 |
| other | Diarrhoea | Gastrointestinal disorders | Atomoxetine | 42 | 228 | 58 |
| other | Nausea | Gastrointestinal disorders | Atomoxetine | 28 | 228 | 47 |
| other | Stomatitis | Gastrointestinal disorders | Atomoxetine | 20 | 228 | 27 |
| other | Toothache | Gastrointestinal disorders | Atomoxetine | 12 | 228 | 12 |
| other | Vomiting | Gastrointestinal disorders | Atomoxetine | 29 | 228 | 45 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atomoxetine | ||
| Total, other adverse events | Atomoxetine | 222 | 228 |
| Total, serious adverse events | Atomoxetine | 6 | 228 |
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/NCT00191386
GET https://conductscience.org/api/trials/v1/NCT00191386/events?page=2