Atomoxetine to Treat Korean Children and Adolescents With... | NCT00568685

ID	Type	Description	Link
B4Z-KL-LYEC

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Atomoxetine 0.2 milligram per kilogram per day (mg/kg/day)	Active Comparator	Drug: Atomoxetine Hydrochloride
Atomoxetine 0.5 mg/kg/day	Active Comparator	Drug: Atomoxetine hydrochloride
Atomoxetine 1.2 mg/kg/day	Active Comparator	Drug: Atomoxetine hydrochloride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atomoxetine Hydrochloride	Drug	Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period	Atomoxetine 0.2 milligram per kilogram per day (mg/kg/day)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	Baseline, Day 42

Secondary Outcomes

Measure	Description	Time Frame
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).	Baseline, Days 7, 14, 42

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
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)	Eli Lilly and Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
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

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Atomoxetine 0.2 Milligrams Per Kilogram, Per Day (mg/kg/Day)	Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
FG001	Atomoxetine 0.5 mg/kg/Day

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Atomoxetine 0.2 mg/kg/Day	Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
BG001	Atomoxetine 0.5 mg/kg/Day	Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
BG002	Atomoxetine 1.2 mg/kg/Day	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.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00051 BG00151 BG00251 BG003153

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Median

Inter-Quartile Range

years

Title

Denominators

Categories

Title	Measurements
	BG0008.87± 2.774(7.63 to 12.09) BG00110.06± 2.178(8.11 to 11.17) BG0029.29± 2.187(8.02 to 11.06)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0004 BG00141 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Korea, Republic of

Title	Measurements
	BG00051 BG00151 BG002

Age-Categorical

Pediatric participant age categories

Number

participants

Title

Denominators

Categories

6-12 years

Title	Measurements
	BG00038 BG00144 BG002

Race/Ethnicity

Number

participants

Title

Denominators

Categories

Korean

Title	Measurements
	BG00051 BG00151 BG002

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).

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00017.51± 5.825 BG001

ADHRS-IV-Parent: Inv. Inattention 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. Inattention 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).

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00021.57± 3.312 BG001

ADHRS-IV-Parent: Inv. Total Scores

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. Total Score consists of all 18 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 54 (highly symptomatic).

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00039.08± 7.896 BG001

Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder Severity Scale (CGI-ADHD-S)

Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder Severity Scale (CGI-ADHD-S) rates severity using a 7-point scale (1=normal, not at all ill; 7=among the most extremely ill subjects). A higher score indicates greater severity of ADHD symptoms.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0005.35± 0.688 BG001

Weight

Mean

Standard Deviation

kilograms

Title

Denominators

Categories

Title	Measurements
	BG00035.67± 12.348 BG00135.54± 10.647 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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

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

ITT population; last observation carried forward (LOCF)

Posted

Mean

Standard Deviation

units on a scale

Baseline, Days 7, 14, 42

ID	Title	Description
OG000	Atomoxetine 0.2 mg/kg/Day	Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
OG001	Atomoxetine 0.5 mg/kg/Day	Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
OG002	Atomoxetine 1.2 mg/kg/Day	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.

Units	Counts
Participants	OG00051 OG00151 OG00251

Title

Denominators

Categories

Day 7

Title	Measurements
	OG000-0.24± 0.480 OG001-0.53± 0.612 OG002-0.30± -.036

Day 14

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002		Mixed Models Analysis		0.0048	This is the p value for CGI-ADHD-S score change at endpoint						95						No	Superiority or Other

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

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

ITT population; LOCF

Posted

Mean

Standard Deviation

units on a scale

Baseline, Days 7, 14, 42

ID	Title	Description
OG000	Atomoxetine 0.2 mg/kg/Day	Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
OG001	Atomoxetine 0.5 mg/kg/Day	Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
OG002	Atomoxetine 1.2 mg/kg/Day	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.

Secondary

Adverse Events Leading to Discontinuation

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

As-treated population

Posted

Number

events

Baseline to Day 42

ID	Title	Description
OG000	0-0.35 mg/kg/Day	Patients received atomoxetine 0-0.35 mg/kg/day
OG001	0.36-0.85 mg/kg/Day	Patients received atomoxetine 0.36-0.85 mg/kg/day
OG002	> 0.85 mg/kg/Day	Patients received atomoxetine >0.85 mg/kg/day

Units	Counts
Participants	OG000

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

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 included all randomized participants (intent-to-treat population)

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Baseline, Day 42

ID	Title	Description
OG000	Atomoxetine 0.2 mg/kg/Day	Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
OG001	Atomoxetine 0.5 mg/kg/Day	Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
OG002	Atomoxetine 1.2 mg/kg/Day	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.

Secondary

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.

As treated population

Posted

Number

participants

Baseline to Day 42

ID	Title	Description
OG000	0-0.35 mg/kg/Day	Patients received atomoxetine 0-0.35 mg/kg/day
OG001	0.36-0.85 mg/kg/Day	Patients received atomoxetine 0.36-0.85 mg/kg/day
OG002	>0.85 mg/kg/Day	Patients received atomoxetine >0.85 mg/kg/day

Secondary

Heart Rate Change From Baseline to Day 42 Endpoint

ITT population

Posted

Mean

Standard Deviation

beats per minute (bpm)

Baseline, Day 42

ID	Title	Description
OG000	Atomoxetine 0.2 mg/kg/Day	Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
OG001	Atomoxetine 0.5 mg/kg/Day	Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
OG002	Atomoxetine 1.2 mg/kg/Day	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.

Units	Counts

Secondary

Temperature Change From Baseline to Day 42 Endpoint

ITT population

Posted

Mean

Standard Deviation

degrees Celsius

Baseline, Day 42

ID	Title	Description
OG000	Atomoxetine 0.2 mg/kg/Day	Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
OG001	Atomoxetine 0.5 mg/kg/Day	Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
OG002	Atomoxetine 1.2 mg/kg/Day	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.

Units	Counts

Secondary

Blood Pressure Change From Baseline to Day 42 Endpoint

ITT population

Posted

Mean

Standard Deviation

mmHg

Baseline, Day 42

ID	Title	Description
OG000	Atomoxetine 0.2 mg/kg/Day	Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
OG001	Atomoxetine 0.5 mg/kg/Day	Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
OG002	Atomoxetine 1.2 mg/kg/Day	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.

Units	Counts

Secondary

Weight Change From Baseline to Day 42 Endpoint

ITT population

Posted

Mean

Standard Deviation

kilograms (kg)

Baseline, Day 42

ID	Title	Description
OG000	Atomoxetine 0.2 mg/kg/Day	Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
OG001	Atomoxetine 0.5 mg/kg/Day	Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
OG002	Atomoxetine 1.2 mg/kg/Day	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.

Units	Counts

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Atomoxetine 0.00-0.35 mg/kg/Day	Patients who received the actual dose range listed.	0	51	15	51
EG001	Atomoxetine 0.36-0.85 mg/kg/Day	Patients who received the actual dose range listed.	1	54	22	54
EG002	Atomoxetine >0.85 mg/kg/Day	Patients who received the actual dose range listed.	1	48	27	48

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Appendicitis	Infections and infestations	MedDRA 11.0	Systematic Assessment		EG0000 events0 affected51 at risk EG0011 events1 affected54 at risk EG0020 events0 affected48 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment		EG0000 events0 affected51 at risk EG0010 events0 affected54 at risk EG0021 events1 affected48 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain upper	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0015 events5 affected54 at risk EG0025 events4 affected48 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected51 at risk EG0013 events3 affected54 at risk EG0022 events2 affected48 at risk
Irritability	General disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected51 at risk EG0012 events2 affected54 at risk EG0025 events4 affected48 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected51 at risk EG0014 events4 affected54 at risk EG0022 events2 affected48 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected51 at risk EG0012 events2 affected54 at risk EG0026 events6 affected48 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0014 events4 affected54 at risk EG0028 events6 affected48 at risk
Dizziness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0013 events3 affected54 at risk EG0020 events0 affected48 at risk
Somnolence	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected54 at risk EG0024 events4 affected48 at risk
Sleep disorder	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected51 at risk EG0010 events0 affected54 at risk EG0021 events1 affected48 at risk

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals