Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00568685

Purpose

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)

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: Atomoxetine Hydrochloride Drug: Atomoxetine hydrochloride	Phase III

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Atomoxetine hydrochloride Atomoxetine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3b, Randomized, Open-Label Assessment of Response to Various Doses of Atomoxetine Hydrochloride in Korean Pediatric Outpatients With Attention-Deficit/Hyperactivity Disorder

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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 [ Time Frame: Change to baseline, 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the efficacy of each dose in reducing the severity of ADHD symptoms, as measured by reduction from baseline to endpoint in Clinical Global Impression-ADHD-Severity (CGI-ADHD-S) score [ Time Frame: Change to baseline, 6 weeks ] [ Designated as safety issue: No ]
To assess the efficacy of each dose in reducing the severity of ADHD symptoms, as measured by Clinical Global Impression-ADHD- Improvement (CGI-ADHD-I) score at endpoint [ Time Frame: Change to baseline, 6 weeks ] [ Designated as safety issue: No ]
To assess the safety and tolerability of atomoxetine at each dosage [ Time Frame: Each study visit ] [ Designated as safety issue: Yes ]

Enrollment:	154
Study Start Date:	November 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Atomoxetine Hydrochloride Patients in Arm 1 receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period
2: Active Comparator	Drug: Atomoxetine hydrochloride Patients in Arm 2 receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period
3: Active Comparator	Drug: Atomoxetine hydrochloride Patients in Arm 3 will 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

Eligibility

Ages Eligible for Study:	6 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568685

Locations

Korea, Republic of
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, Korea, Republic of, 420-767
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.
In Cheon, Korea, Republic of, 405-760
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, Korea, Republic of, 135-720

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	11710, B4Z-KL-LYEC
Study First Received:	December 4, 2007
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00568685 History of Changes
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Neurotransmitter Agents
Adrenergic Agents
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Atomoxetine
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Atomoxetine

Dyskinesias
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations

ClinicalTrials.gov processed this record on May 06, 2009