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Clinical Trial Results:
A Phase 3b, Randomized, Open-Label Assessment of Response to Various Doses of Atomoxetine Hydrochloride in Korean Pediatric Outpatients With Attention-Deficit/Hyperactivity Disorder

Summary
EudraCT number	2017-000685-29
Trial protocol	Outside EU/EEA
Global end of trial date	01 Nov 2008

Results information
Results version number	v1(current)
This version publication date	22 Dec 2021
First version publication date	22 Dec 2021
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

B4Z-KL-LYEC

ISRCTN number

US NCT number

NCT00568685

WHO universal trial number (UTN)

Other trial identifiers

Trial ID: 11710

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

Lilly Corporate Center, Indianapolis, IN, United States, 46285

Public contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877-CTLilly, EU_Lilly_Clinical_Trials@lilly.com

Scientific contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559, EU_Lilly_Clinical_Trials@lilly.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

01 Nov 2008

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

01 Nov 2008

Was the trial ended prematurely?

Main objective of the trial

To assess graphically dose-response with atomoxetine, as measured by change from baseline to endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) total score

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.

Background therapy

Evidence for comparator

Actual start date of recruitment

01 Nov 2007

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Korea, Republic of: 153

Worldwide total number of subjects

153

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

126

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Not Applicable

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Atomoxetine 0.2 mg/kg/Day

Arm description

Participants receive 0.2 milligrams Per Kilogram, Per Day (mg/kg/day) atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.

Arm type

Experimental

Investigational medicinal product name

Atomoxetine

Investigational medicinal product code

Other name

LY139603; Strattera

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants receive 0.2 mg/kg/day atomoxetine administered orally.

Atomoxetine 0.5 mg/kg/Day

Arm description

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

Arm type

Experimental

Investigational medicinal product name

Atomoxetine

Investigational medicinal product code

Other name

LY139603; Strattera

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants receive 0.5 mg/kg/day atomoxetine administered orally.

Atomoxetine 1.2 mg/kg/Day

Arm description

Participants initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Participants 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.

Arm type

Experimental

Investigational medicinal product name

Atomoxetine

Investigational medicinal product code

Other name

LY139603; Strattera

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants receive 1.2 mg/kg/day atomoxetine administered orally.

Number of subjects in period 1	Atomoxetine 0.2 mg/kg/Day	Atomoxetine 0.5 mg/kg/Day	Atomoxetine 1.2 mg/kg/Day
Started	51	51	51
Completed	41	46	46
Not completed	10	5	5
Consent withdrawn by subject	7	2	2
Adverse event, non-fatal	2	3	3
Protocol deviation	1	-	-

Baseline characteristics

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Reporting group title

Atomoxetine 0.2 mg/kg/Day

Reporting group description

Participants receive 0.2 milligrams Per Kilogram, Per Day (mg/kg/day) atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.

Reporting group title

Atomoxetine 0.5 mg/kg/Day

Reporting group description

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

Reporting group title

Atomoxetine 1.2 mg/kg/Day

Reporting group description

Reporting group values	Atomoxetine 0.2 mg/kg/Day	Atomoxetine 0.5 mg/kg/Day	Atomoxetine 1.2 mg/kg/Day	Total
Number of subjects	51	51	51	153
Age categorical
Units: Subjects
In utero				0
Preterm newborn infants (gestational age < 37 wks)				0
Newborns (0-27 days)				0
Infants and toddlers (28 days-23 months)				0
Children (2-11 years)				0
Adolescents (12-17 years)				0
Adults (18-64 years)				0
From 65-84 years				0
85 years and over				0
Age continuous
Units: years
geometric mean (inter-quartile range (Q1-Q3))	8.87 (7.63 to 12.09)	10.06 (8.11 to 11.17)	9.29 (8.02 to 11.06)	-
Gender categorical
Units: Subjects
Female	4	41	40	85
Male	47	10	11	68
Race/Ethnicity
Units: Subjects
Korean	51	51	51	153
ADHD Rating Scale-IV-Parent:Investigator Rated Hyperactivity Subscale Score
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) is an 18-item scale with one item for each of 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnosis for ADHD. Hyperactive/Impulsive Subscale consists of 9 items. Each item is scored on a 4 point scale (0=never or rarely; 1=sometimes; 2=often; 3=very often) for total score range of 0 (no symptoms) to 27 (highly symptomatic).
Units: Units on a Scale
arithmetic mean (standard deviation)	17.51 ( 5.825 )	16.61 ( 5.107 )	15.96 ( 5.553 )	-

End points

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Reporting group title

Atomoxetine 0.2 mg/kg/Day

Reporting group description

Participants receive 0.2 milligrams Per Kilogram, Per Day (mg/kg/day) atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.

Reporting group title

Atomoxetine 0.5 mg/kg/Day

Reporting group description

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

Reporting group title

Atomoxetine 1.2 mg/kg/Day

Reporting group description

Subject analysis set title

0-0.35 mg/kg/Day

Subject analysis set type

Per protocol

Subject analysis set description

Participants received atomoxetine 0-0.35 mg/kg/day

Subject analysis set title

0.36-0.85 mg/kg/Day

Subject analysis set type

Per protocol

Subject analysis set description

Participants received atomoxetine 0.36-0.85 mg/kg/day

Subject analysis set title

>0.85 mg/kg/Day

Subject analysis set type

Per protocol

Subject analysis set description

Participants received atomoxetine >0.85 mg/kg/day

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

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End point title

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

End point description

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). Analysis Population Description (APD): Analysis included all randomized participants (intent-to-treat population)

End point type

Primary

End point timeframe

Baseline, Day 42

End point values	Atomoxetine 0.2 mg/kg/Day	Atomoxetine 0.5 mg/kg/Day	Atomoxetine 1.2 mg/kg/Day
Number of subjects analysed	51	51	51
Units: units on a scale
least squares mean (confidence interval 95%)	-9.55 (-12.03 to -7.07)	-12.31 (-14.76 to -9.85)	-14.51 (-16.99 to -12.04)

ADHDRS-IV-Parent:Inv

Comparison groups

Atomoxetine 0.2 mg/kg/Day v Atomoxetine 0.5 mg/kg/Day v Atomoxetine 1.2 mg/kg/Day

Number of subjects included in analysis

153

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.024

Method

ANCOVA

Confidence interval

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

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End point title

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

End point description

Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). APD: ITT population; last observation carried forward (LOCF)

End point type

Secondary

End point timeframe

Baseline, Days 7, 14, 42

End point values	Atomoxetine 0.2 mg/kg/Day	Atomoxetine 0.5 mg/kg/Day	Atomoxetine 1.2 mg/kg/Day
Number of subjects analysed	51	51	51
Units: units on a scale
geometric mean (standard deviation)
Day 7	-0.24 ( 0.480 )	-0.53 ( 0.612 )	-0.30 ( 0.036 )
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 )

CGI-ADHD-S

Comparison groups

Atomoxetine 0.5 mg/kg/Day v Atomoxetine 1.2 mg/kg/Day v Atomoxetine 0.2 mg/kg/Day

Number of subjects included in analysis

153

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0048

Method

Mixed models analysis

Confidence interval

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

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End point title

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

End point description

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

End point type

Secondary

End point timeframe

Baseline, Days 7, 14, 42

End point values	Atomoxetine 0.2 mg/kg/Day	Atomoxetine 0.5 mg/kg/Day	Atomoxetine 1.2 mg/kg/Day
Number of subjects analysed	51	51	51
Units: units on a scale
geometric mean (standard deviation)
Day 7	3.57 ( 0.645 )	3.22 ( 0.642 )	3.54 ( 0.813 )
Day 14	3.25 ( 0.729 )	3.20 ( 0.957 )	2.98 ( 0.721 )
Day 42	3.24 ( 0.970 )	3.09 ( 0.952 )	2.77 ( 0.973 )
LOCF Endpoint	3.29 ( 0.957 )	3.16 ( 0.946 )	2.80 ( 0.969 )

CGI-ADHD-I

Comparison groups

Atomoxetine 0.2 mg/kg/Day v Atomoxetine 0.5 mg/kg/Day v Atomoxetine 1.2 mg/kg/Day

Number of subjects included in analysis

153

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0153

Method

Mixed models analysis

Confidence interval

Secondary: Adverse Events Leading to Discontinuation

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End point title

Adverse Events Leading to Discontinuation

End point description

Adverse Events (Preferred Term) leading to discontinuation by decreasing frequency APD: As-treated population

End point type

Secondary

End point timeframe

Baseline to Day 42

End point values	0-0.35 mg/kg/Day	0.36-0.85 mg/kg/Day	>0.85 mg/kg/Day
Number of subjects analysed	51	54	48
Units: events
number (not applicable)
Anorexia	0	1	0
Appendicitis	0	1	0
Dizziness	0	1	0
Dysphemia	0	0	1
Irritability	1	0	0
Sedation	0	0	1
Decreased appetite	0	1	0

Adverse Events Leading to Discontinuation

Comparison groups

0-0.35 mg/kg/Day v 0.36-0.85 mg/kg/Day v >0.85 mg/kg/Day

Number of subjects included in analysis

153

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.45

Method

Fisher exact

Confidence interval

Secondary: Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary

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End point title

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

End point description

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.

End point type

Secondary

End point timeframe

Baseline to Day 42

End point values	0-0.35 mg/kg/Day	0.36-0.85 mg/kg/Day	>0.85 mg/kg/Day
Number of subjects analysed	51	54	48
Units: participants
number (not applicable)	0	0	0

No statistical analyses for this end point

Secondary: Heart Rate Change From Baseline to Day 42 Endpoint

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End point title

Heart Rate Change From Baseline to Day 42 Endpoint

End point description

APD: ITT population

End point type

Secondary

End point timeframe

Baseline, Day 42

End point values	Atomoxetine 0.2 mg/kg/Day	Atomoxetine 0.5 mg/kg/Day	Atomoxetine 1.2 mg/kg/Day
Number of subjects analysed	51	51	51
Units: beats per minute (bpm)
geometric mean (standard deviation)
Baseline	87.86 ( 12.324 )	85.78 ( 10.769 )	90.10 ( 12.852 )
Day 42	90.43 ( 10.278 )	90.35 ( 11.028 )	93.89 ( 13.287 )
Change at endpoint	2.59 ( 13.041 )	5.24 ( 13.621 )	4.98 ( 14.649 )

Heart Rate Change

Comparison groups

Atomoxetine 0.2 mg/kg/Day v Atomoxetine 0.5 mg/kg/Day v Atomoxetine 1.2 mg/kg/Day

Number of subjects included in analysis

153

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8005

Method

ANOVA

Confidence interval

Secondary: Temperature Change From Baseline to Day 42 Endpoint

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End point title

Temperature Change From Baseline to Day 42 Endpoint

End point description

APD: ITT population

End point type

Secondary

End point timeframe

Baseline, Day 42

End point values	Atomoxetine 0.2 mg/kg/Day	Atomoxetine 0.5 mg/kg/Day	Atomoxetine 1.2 mg/kg/Day
Number of subjects analysed	51	51	51
Units: degrees Celsius
geometric mean (standard deviation)
Baseline	36.63 ( 0.260 )	36.56 ( 0.397 )	36.50 ( 0.400 )
Day 42	36.58 ( 0.331 )	36.55 ( 0.332 )	36.59 ( 0.270 )
Change at endpoint	-0.05 ( 0.343 )	-0.02 ( 0.339 )	0.07 ( 0.327 )

Temperature Change

Comparison groups

Atomoxetine 0.5 mg/kg/Day v Atomoxetine 1.2 mg/kg/Day v Atomoxetine 0.2 mg/kg/Day

Number of subjects included in analysis

153

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4128

Method

ANOVA

Confidence interval

Secondary: Blood Pressure Change From Baseline to Day 42 Endpoint

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End point title

Blood Pressure Change From Baseline to Day 42 Endpoint

End point description

APD: ITT population

End point type

Secondary

End point timeframe

Baseline, Day 42

End point values	Atomoxetine 0.2 mg/kg/Day	Atomoxetine 0.5 mg/kg/Day	Atomoxetine 1.2 mg/kg/Day
Number of subjects analysed	51	51	51
Units: mmHg
geometric mean (standard deviation)
Systolic Baseline	105.98 ( 12.888 )	102.49 ( 11.279 )	106.12 ( 13.749 )
Systolic Day 42	107.82 ( 14.440 )	104.98 ( 10.988 )	108.48 ( 11.067 )
Systolic Change at Endpoint	0.98 ( 16.535 )	2.35 ( 12.122 )	1.72 ( 13.391 )
Diastolic Baseline	66.53 ( 10.567 )	65.39 ( 11.742 )	66.78 ( 11.524 )
Diastolic Day 42	67.45 ( 10.199 )	68.78 ( 11.677 )	70.02 ( 8.734 )
Diastolic Change at Endpoint	0.16 ( 13.201 )	3.65 ( 12.058 )	2.17 ( 13.200 )

Systolic Change

Comparison groups

Atomoxetine 0.2 mg/kg/Day v Atomoxetine 0.5 mg/kg/Day v Atomoxetine 1.2 mg/kg/Day

Number of subjects included in analysis

153

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.9761

Method

ANOVA

Confidence interval

Diastolic Change

Comparison groups

Atomoxetine 0.2 mg/kg/Day v Atomoxetine 0.5 mg/kg/Day v Atomoxetine 1.2 mg/kg/Day

Number of subjects included in analysis

153

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6419

Method

ANOVA

Confidence interval

Secondary: Weight Change From Baseline to Day 42 Endpoint

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End point title

Weight Change From Baseline to Day 42 Endpoint

End point description

End point type

Secondary

End point timeframe

Baseline, Day 42

End point values	Atomoxetine 0.2 mg/kg/Day	Atomoxetine 0.5 mg/kg/Day	Atomoxetine 1.2 mg/kg/Day
Number of subjects analysed	51	51	51
Units: kilograms (kg)
geometric mean (standard deviation)
Baseline	35.67 ( 12.348 )	35.54 ( 10.647 )	35.48 ( 11.536 )
Day 42	36.10 ( 12.524 )	35.72 ( 11.305 )	36.39 ( 11.708 )
Change at Endpoint	0.37 ( 1.500 )	-0.08 ( 1.155 )	-0.15 ( 1.093 )

Weight Change

Comparison groups

Atomoxetine 0.2 mg/kg/Day v Atomoxetine 0.5 mg/kg/Day v Atomoxetine 1.2 mg/kg/Day

Number of subjects included in analysis

153

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2213

Method

ANOVA

Confidence interval

Adverse events

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Timeframe for reporting adverse events

Baseline, End of the study

Adverse event reporting additional description

The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

11.0

Reporting group title

Atomoxetine 0.00-0.35 mg/kg/Day

Reporting group description

Patients who received the actual dose range listed.

Reporting group title

Atomoxetine 0.36-0.85 mg/kg/Day

Reporting group description

Patients who received the actual dose range listed.

Reporting group title

Atomoxetine >0.85 mg/kg/Day

Reporting group description

Patients who received the actual dose range listed.

Serious adverse events	Atomoxetine 0.00-0.35 mg/kg/Day	Atomoxetine 0.36-0.85 mg/kg/Day	Atomoxetine >0.85 mg/kg/Day
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 51 (0.00%)	1 / 54 (1.85%)	1 / 48 (2.08%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
Injury, poisoning and procedural complications
Road traffic accident
subjects affected / exposed	0 / 51 (0.00%)	0 / 54 (0.00%)	1 / 48 (2.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	0 / 51 (0.00%)	1 / 54 (1.85%)	0 / 48 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Atomoxetine 0.00-0.35 mg/kg/Day	Atomoxetine 0.36-0.85 mg/kg/Day	Atomoxetine >0.85 mg/kg/Day
Total subjects affected by non serious adverse events
subjects affected / exposed	15 / 51 (29.41%)	22 / 54 (40.74%)	27 / 48 (56.25%)
Nervous system disorders
Dizziness
subjects affected / exposed	1 / 51 (1.96%)	3 / 54 (5.56%)	0 / 48 (0.00%)
occurrences all number	1	3	0
Somnolence
subjects affected / exposed	0 / 51 (0.00%)	1 / 54 (1.85%)	4 / 48 (8.33%)
occurrences all number	0	1	4
General disorders and administration site conditions
Irritability
subjects affected / exposed	2 / 51 (3.92%)	2 / 54 (3.70%)	4 / 48 (8.33%)
occurrences all number	2	2	5
Gastrointestinal disorders
Abdominal pain upper
subjects affected / exposed	0 / 51 (0.00%)	5 / 54 (9.26%)	4 / 48 (8.33%)
occurrences all number	0	5	5
Nausea
subjects affected / exposed	2 / 51 (3.92%)	3 / 54 (5.56%)	2 / 48 (4.17%)
occurrences all number	2	3	2
Psychiatric disorders
Sleep disorder
subjects affected / exposed	4 / 51 (7.84%)	0 / 54 (0.00%)	1 / 48 (2.08%)
occurrences all number	4	0	1
Infections and infestations
Nasopharyngitis
subjects affected / exposed	3 / 51 (5.88%)	4 / 54 (7.41%)	2 / 48 (4.17%)
occurrences all number	3	4	2
Metabolism and nutrition disorders
Anorexia
subjects affected / exposed	2 / 51 (3.92%)	2 / 54 (3.70%)	6 / 48 (12.50%)
occurrences all number	2	2	6
Decreased appetite
subjects affected / exposed	1 / 51 (1.96%)	4 / 54 (7.41%)	6 / 48 (12.50%)
occurrences all number	1	4	8

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
A Phase 3b, Randomized, Open-Label Assessment of Response to Various Doses of Atomoxetine Hydrochloride in Korean Pediatric Outpatients With Attention-Deficit/Hyperactivity Disorder

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

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

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

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

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

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

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

Secondary: Adverse Events Leading to Discontinuation

Secondary: Adverse Events Leading to Discontinuation

Secondary: Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary

Secondary: Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary

Secondary: Heart Rate Change From Baseline to Day 42 Endpoint

Secondary: Heart Rate Change From Baseline to Day 42 Endpoint

Secondary: Temperature Change From Baseline to Day 42 Endpoint

Secondary: Temperature Change From Baseline to Day 42 Endpoint

Secondary: Blood Pressure Change From Baseline to Day 42 Endpoint

Secondary: Blood Pressure Change From Baseline to Day 42 Endpoint

Secondary: Weight Change From Baseline to Day 42 Endpoint

Secondary: Weight Change From Baseline to Day 42 Endpoint

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical trials

Clinical Trial Results: A Phase 3b, Randomized, Open-Label Assessment of Response to Various Doses of Atomoxetine Hydrochloride in Korean Pediatric Outpatients With Attention-Deficit/Hyperactivity Disorder

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

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

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

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

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

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

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

Secondary: Adverse Events Leading to Discontinuation

Secondary: Adverse Events Leading to Discontinuation

Secondary: Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary

Secondary: Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary

Secondary: Heart Rate Change From Baseline to Day 42 Endpoint

Secondary: Heart Rate Change From Baseline to Day 42 Endpoint

Secondary: Temperature Change From Baseline to Day 42 Endpoint

Secondary: Temperature Change From Baseline to Day 42 Endpoint

Secondary: Blood Pressure Change From Baseline to Day 42 Endpoint

Secondary: Blood Pressure Change From Baseline to Day 42 Endpoint

Secondary: Weight Change From Baseline to Day 42 Endpoint

Secondary: Weight Change From Baseline to Day 42 Endpoint

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical Trial Results:
A Phase 3b, Randomized, Open-Label Assessment of Response to Various Doses of Atomoxetine Hydrochloride in Korean Pediatric Outpatients With Attention-Deficit/Hyperactivity Disorder