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CompletedNCT00568685Updated Jan 26, 2010Results posted

Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

A Phase 3 interventional study of Atomoxetine Hydrochloride and Atomoxetine hydrochloride in Attention Deficit Hyperactivity Disorder, sponsored by Eli Lilly and Company. Completed at 3 sites in South Korea. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2010-01-26.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
153
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study 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)

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder
03

In context

Attention Deficit Disorder with Hyperactivity

1,547 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 254 are open to participants now.

This study's enrollment of 153 is above the median of 71 across 1,233 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.

Browse Eli Lilly and Company studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
153 participants (actual)

Study arms

  • Active comparator
    Atomoxetine 0.2 milligram per kilogram per day (mg/kg/day)

    Drug: Atomoxetine Hydrochloride

  • Active comparator
    Atomoxetine 0.5 mg/kg/day

    Drug: Atomoxetine hydrochloride

  • Active comparator
    Atomoxetine 1.2 mg/kg/day

    Drug: Atomoxetine hydrochloride

Interventions

  • DrugAtomoxetine Hydrochloride

    Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period

    Also known as: LY139603, Strattera

  • DrugAtomoxetine hydrochloride

    Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period

    Also known as: LY139603, Strattera

  • DrugAtomoxetine hydrochloride

    Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days

    Also known as: LY139603, Strattera

06

What researchers measure

Primary outcomes

  1. 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

    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).

    Time frame: Baseline, Day 42

Secondary outcomes

  1. 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

    Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).

    Time frame: Baseline, Days 7, 14, 42

  2. 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

    Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened)

    Time frame: Baseline, Days 7, 14, 42

  3. Adverse Events Leading to Discontinuation

    Adverse Events (Preferred Term) leading to discontinuation by decreasing frequency

    Time frame: Baseline to Day 42

  4. Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary

    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.

    Time frame: Baseline to Day 42

  5. Heart Rate Change From Baseline to Day 42 Endpoint

    Time frame: Baseline, Day 42

  6. Temperature Change From Baseline to Day 42 Endpoint

    Time frame: Baseline, Day 42

  7. Blood Pressure Change From Baseline to Day 42 Endpoint

    Time frame: Baseline, Day 42

  8. Weight Change From Baseline to Day 42 Endpoint

    Time frame: Baseline, Day 42

07

Results

Posted Dec 14, 2009

Participant flow

Participant flow — Overall Study
MilestoneAtomoxetine 0.2 Milligrams Per Kilogram, Per Day (mg/kg/Day)Atomoxetine 0.5 mg/kg/DayAtomoxetine 1.2 mg/kg/Day
Started515151
Completed414646
Not completed1055
Withdrew: Adverse event233
Withdrew: Withdrawal by subject722
Withdrew: Protocol violation100

Outcome measures

SecondaryChange 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

Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).

Time frame:
Baseline, Days 7, 14, 42
Reported as:
Mean · 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
units on a scaleAtomoxetine 0.2 mg/kg/DayAtomoxetine 0.5 mg/kg/DayAtomoxetine 1.2 mg/kg/Day
Day 7-0.24 ± 0.480-0.53 ± 0.612-0.30 ± -.036
Day 14-0.73 ± 0.736-0.90 ± 0.918-0.92 ± 0.786
Day 42-1.04 ± 0.729-1.30 ± 1.121-1.56 ± 1.090
LOCF Endpoint-0.98 ± 0.750-1.22 ± 1.119-1.54 ± 1.073
Statistical analysis
  • Atomoxetine 0.2 mg/kg/Day vs Atomoxetine 0.5 mg/kg/Day vs Atomoxetine 1.2 mg/kg/Day · Mixed Models Analysis · p = 0.0048 (This is the p value for CGI-ADHD-S score change at endpoint)
SecondaryChange 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

Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened)

Time frame:
Baseline, Days 7, 14, 42
Reported as:
Mean · units on a scale
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
units on a scaleAtomoxetine 0.2 mg/kg/DayAtomoxetine 0.5 mg/kg/DayAtomoxetine 1.2 mg/kg/Day
Day 73.57 ± 0.6453.22 ± 0.6423.54 ± 0.813
Day 143.25 ± 0.7293.20 ± 0.9572.98 ± 0.721
Day 423.24 ± 0.9703.09 ± 0.9522.77 ± 0.973
LOCF Endpoint3.29 ± 0.9573.16 ± 0.9462.80 ± 0.969
Statistical analysis
  • Atomoxetine 0.2 mg/kg/Day vs Atomoxetine 0.5 mg/kg/Day vs Atomoxetine 1.2 mg/kg/Day · Mixed Models Analysis · p = 0.0153 (This is the p value for CGI-ADHD-I score change at endpoint)
SecondaryAdverse Events Leading to Discontinuation

Adverse Events (Preferred Term) leading to discontinuation by decreasing frequency

Time frame:
Baseline to Day 42
Reported as:
Number · events
Adverse Events Leading to Discontinuation
events0-0.35 mg/kg/Day0.36-0.85 mg/kg/Day> 0.85 mg/kg/Day
Anorexia010
Appendicitis010
Dizziness010
Dysphemia001
Irritability100
Sedation001
Decreased appetite010
Statistical analysis
  • 0-0.35 mg/kg/Day vs 0.36-0.85 mg/kg/Day vs > 0.85 mg/kg/Day · Fisher Exact · p = .4500 (P-value relates to the sum of adverse events leading to discontinuation.)
PrimaryChange 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

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).

Time frame:
Baseline, Day 42
Reported as:
Least squares mean · units on a scale
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
units on a scaleAtomoxetine 0.2 mg/kg/DayAtomoxetine 0.5 mg/kg/DayAtomoxetine 1.2 mg/kg/Day
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 ± 7.758-12.31 ± 7.064-14.51 ± 7.216
Statistical analysis
  • Atomoxetine 0.2 mg/kg/Day vs Atomoxetine 0.5 mg/kg/Day vs Atomoxetine 1.2 mg/kg/Day · ANCOVA · p = 0.0240
SecondaryIncidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary

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.

Time frame:
Baseline to Day 42
Reported as:
Number · participants
Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary
participants0-0.35 mg/kg/Day0.36-0.85 mg/kg/Day>0.85 mg/kg/Day
Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary000
SecondaryHeart Rate Change From Baseline to Day 42 Endpoint
Time frame:
Baseline, Day 42
Reported as:
Mean · beats per minute (bpm)
Heart Rate Change From Baseline to Day 42 Endpoint
beats per minute (bpm)Atomoxetine 0.2 mg/kg/DayAtomoxetine 0.5 mg/kg/DayAtomoxetine 1.2 mg/kg/Day
Baseline87.86 ± 12.32485.78 ± 10.76990.10 ± 12.852
Day 4290.43 ± 10.27890.35 ± 11.02893.89 ± 13.287
Change at endpoint2.59 ± 13.0415.24 ± 13.6214.98 ± 14.649
Statistical analysis
  • Atomoxetine 0.2 mg/kg/Day vs Atomoxetine 0.5 mg/kg/Day vs Atomoxetine 1.2 mg/kg/Day · ANOVA · p = 0.8005 (This is the p value for heart rate change at endpoint)
SecondaryTemperature Change From Baseline to Day 42 Endpoint
Time frame:
Baseline, Day 42
Reported as:
Mean · degrees Celsius
Temperature Change From Baseline to Day 42 Endpoint
degrees CelsiusAtomoxetine 0.2 mg/kg/DayAtomoxetine 0.5 mg/kg/DayAtomoxetine 1.2 mg/kg/Day
Baseline36.63 ± 0.26036.56 ± 0.39736.50 ± 0.400
Day 4236.58 ± 0.33136.55 ± 0.33236.59 ± 0.270
Change at endpoint-0.05 ± 0.343-0.02 ± 0.3390.07 ± 0.327
Statistical analysis
  • Atomoxetine 0.2 mg/kg/Day vs Atomoxetine 0.5 mg/kg/Day vs Atomoxetine 1.2 mg/kg/Day · ANOVA · p = 0.4128 (This is the p value for temperature change at endpoint)
SecondaryBlood Pressure Change From Baseline to Day 42 Endpoint
Time frame:
Baseline, Day 42
Reported as:
Mean · mmHg
Blood Pressure Change From Baseline to Day 42 Endpoint
mmHgAtomoxetine 0.2 mg/kg/DayAtomoxetine 0.5 mg/kg/DayAtomoxetine 1.2 mg/kg/Day
Systolic Baseline105.98 ± 12.888102.49 ± 11.279106.12 ± 13.749
Systolic Day 42107.82 ± 14.440104.98 ± 10.988108.48 ± 11.067
Systolic Change at Endpoint0.98 ± 16.5352.35 ± 12.1221.72 ± 13.391
Diastolic Baseline66.53 ± 10.56765.39 ± 11.74266.78 ± 11.524
Diastolic Day 4267.45 ± 10.19968.78 ± 11.67770.02 ± 8.734
Diastolic Change at Endpoint0.16 ± 13.2013.65 ± 12.0582.17 ± 13.200
Statistical analysis
  • Atomoxetine 0.2 mg/kg/Day vs Atomoxetine 0.5 mg/kg/Day vs Atomoxetine 1.2 mg/kg/Day · ANOVA · p = 0.9761 (This is the p value for systolic change at endpoint)
  • Atomoxetine 0.2 mg/kg/Day vs Atomoxetine 0.5 mg/kg/Day vs Atomoxetine 1.2 mg/kg/Day · ANOVA · p = 0.6419 (This is the p value for diastolic change at endpoint)
SecondaryWeight Change From Baseline to Day 42 Endpoint
Time frame:
Baseline, Day 42
Reported as:
Mean · kilograms (kg)
Weight Change From Baseline to Day 42 Endpoint
kilograms (kg)Atomoxetine 0.2 mg/kg/DayAtomoxetine 0.5 mg/kg/DayAtomoxetine 1.2 mg/kg/Day
Baseline35.67 ± 12.34835.54 ± 10.64735.48 ± 11.536
Day 4236.10 ± 12.52435.72 ± 11.30536.39 ± 11.708
Change at Endpoint0.37 ± 1.500-0.08 ± 1.155-0.15 ± 1.093
Statistical analysis
  • Atomoxetine 0.2 mg/kg/Day vs Atomoxetine 0.5 mg/kg/Day vs Atomoxetine 1.2 mg/kg/Day · ANOVA · p = 0.2213 (This is the p value for weight change at endpoint)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Atomoxetine 0.00-0.35 mg/kg/Day—0/51 (0%)15/51 (29.4%)
Atomoxetine 0.36-0.85 mg/kg/Day—1/54 (1.9%)22/54 (40.7%)
Atomoxetine >0.85 mg/kg/Day—1/48 (2.1%)27/48 (56.3%)
Most frequent serious events
Most frequent serious events
EventAtomoxetine 0.00-0.35 mg/kg/DayAtomoxetine 0.36-0.85 mg/kg/DayAtomoxetine >0.85 mg/kg/Day
Road traffic accidentInjury, poisoning and procedural complications0/510/541/48
AppendicitisInfections and infestations0/511/540/48
Most frequent other events
Most frequent other events
EventAtomoxetine 0.00-0.35 mg/kg/DayAtomoxetine 0.36-0.85 mg/kg/DayAtomoxetine >0.85 mg/kg/Day
AnorexiaMetabolism and nutrition disorders2/512/546/48
Decreased appetiteMetabolism and nutrition disorders1/514/546/48
Abdominal pain upperGastrointestinal disorders0/515/544/48
IrritabilityGeneral disorders2/512/544/48
SomnolenceNervous system disorders0/511/544/48
Sleep disorderPsychiatric disorders4/510/541/48
NasopharyngitisInfections and infestations3/514/542/48
NauseaGastrointestinal disorders2/513/542/48
DizzinessNervous system disorders1/513/540/48

Baseline characteristics

Age Continuous
Age Continuous(years)Atomoxetine 0.2 mg/kg/DayAtomoxetine 0.5 mg/kg/DayAtomoxetine 1.2 mg/kg/DayTotal
Median8.87 ± 2.77410.06 ± 2.1789.29 ± 2.1879.41 ± 2.382
Sex: Female, Male
Sex: Female, Male(Participants)Atomoxetine 0.2 mg/kg/DayAtomoxetine 0.5 mg/kg/DayAtomoxetine 1.2 mg/kg/DayTotal
Female4414085
Male47101168
Region of Enrollment
Region of Enrollment(participants)Atomoxetine 0.2 mg/kg/DayAtomoxetine 0.5 mg/kg/DayAtomoxetine 1.2 mg/kg/DayTotal
Korea, Republic of515151153
Age-Categorical
Age-Categorical(participants)Atomoxetine 0.2 mg/kg/DayAtomoxetine 0.5 mg/kg/DayAtomoxetine 1.2 mg/kg/DayTotal
6-12 years384444126
13-18 years137727
Race/Ethnicity
Race/Ethnicity(participants)Atomoxetine 0.2 mg/kg/DayAtomoxetine 0.5 mg/kg/DayAtomoxetine 1.2 mg/kg/DayTotal
Korean515151153
ADHD Rating Scale-IV-Parent:Investigator Rated Hyperactivity Subscale Score
ADHD Rating Scale-IV-Parent:Investigator Rated Hyperactivity Subscale Score(units on a scale)Atomoxetine 0.2 mg/kg/DayAtomoxetine 0.5 mg/kg/DayAtomoxetine 1.2 mg/kg/DayTotal
Mean17.51 ± 5.82516.61 ± 5.10715.96 ± 5.55316.69 ± 5.504
ADHRS-IV-Parent: Inv. Inattention Subscale Score
ADHRS-IV-Parent: Inv. Inattention Subscale Score(units on a scale)Atomoxetine 0.2 mg/kg/DayAtomoxetine 0.5 mg/kg/DayAtomoxetine 1.2 mg/kg/DayTotal
Mean21.57 ± 3.31221.06 ± 3.63020.20 ± 3.47620.94 ± 3.499
ADHRS-IV-Parent: Inv. Total Scores
ADHRS-IV-Parent: Inv. Total Scores(units on a scale)Atomoxetine 0.2 mg/kg/DayAtomoxetine 0.5 mg/kg/DayAtomoxetine 1.2 mg/kg/DayTotal
Mean39.08 ± 7.89637.67 ± 7.06436.16 ± 7.34137.63 ± 7.489

2 further baseline measures are reported on the registry.

08

Study locations

3 sites
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Bucheon-si, 420-767, South Korea
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Incheon, 405-760, South Korea
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Seoul, 135-720, South Korea
09

References and documents

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2007, a primary completion of Nov 2008 and a completion of Nov 2008. It does not say whether these dates are actual or estimated.

Results were first posted in Dec 2009, 1 year 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 4, 2007
First posted
Dec 6, 2007
Start
Nov 2007
Primary completionActual
Nov 2008
CompletionActual
Nov 2008
Results first posted
Dec 14, 2009
Last update
Jan 26, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 26, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00568685
Lead sponsor
Eli Lilly and Company
First posted
Dec 6, 2007
Start date
Nov 2007
Primary completion
Nov 2008
Completion
Nov 2008
Results posted
Dec 14, 2009
Last update
Jan 26, 2010

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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