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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00568685
First received: December 4, 2007
Last updated: January 19, 2010
Last verified: January 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 [ Time Frame: Baseline, Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Baseline, Days 7, 14, 42 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Baseline, Days 7, 14, 42 ] [ Designated as safety issue: No ]
  • Adverse Events Leading to Discontinuation [ Time Frame: Baseline to Day 42 ] [ Designated as safety issue: Yes ]
  • Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary [ Time Frame: Baseline to Day 42 ] [ Designated as safety issue: Yes ]
  • Heart Rate Change From Baseline to Day 42 Endpoint [ Time Frame: Baseline, Day 42 ] [ Designated as safety issue: No ]
  • Temperature Change From Baseline to Day 42 Endpoint [ Time Frame: Baseline, Day 42 ] [ Designated as safety issue: No ]
  • Blood Pressure Change From Baseline to Day 42 Endpoint [ Time Frame: Baseline, Day 42 ] [ Designated as safety issue: No ]
  • Weight Change From Baseline to Day 42 Endpoint [ Time Frame: Baseline, Day 42 ] [ Designated as safety issue: No ]

Enrollment: 153
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
Active Comparator: Atomoxetine 0.2 milligram per kilogram per day (mg/kg/day) Drug: Atomoxetine 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
Other Names:
  • LY139603
  • Strattera
Active Comparator: Atomoxetine 0.5 mg/kg/day Drug: Atomoxetine 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
Other Names:
  • LY139603
  • Strattera
Active Comparator: Atomoxetine 1.2 mg/kg/day Drug: Atomoxetine 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

Other Names:
  • LY139603
  • Strattera

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00568685     History of Changes
Other Study ID Numbers: 11710, B4Z-KL-LYEC
Study First Received: December 4, 2007
Results First Received: November 11, 2009
Last Updated: January 19, 2010
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Nervous System Diseases
Hyperkinesis
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014