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

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ClinicalTrials.gov Identifier: NCT00568685
Recruitment Status : Completed
First Posted : December 6, 2007
Results First Posted : December 14, 2009
Last Update Posted : January 26, 2010
Sponsor:
Information provided by:
Eli Lilly and Company

Brief 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)

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Atomoxetine Hydrochloride Drug: Atomoxetine hydrochloride Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 [ Time Frame: Baseline, Day 42 ]

Secondary Outcome Measures :
  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 [ 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 [ Time Frame: Baseline, Days 7, 14, 42 ]
  3. Adverse Events Leading to Discontinuation [ Time Frame: Baseline to Day 42 ]
  4. Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary [ 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 ]


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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00568685     History of Changes
Other Study ID Numbers: 11710
B4Z-KL-LYEC
First Posted: December 6, 2007    Key Record Dates
Results First Posted: December 14, 2009
Last Update Posted: January 26, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Nervous System Diseases
Hyperkinesis
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs