ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

December 4, 2007
December 6, 2007
November 11, 2009
December 14, 2009
January 26, 2010
November 2007
November 2008   (Final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00568685 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Adverse Events Leading to Discontinuation [ Time Frame: Baseline to Day 42 ]
  • Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary [ Time Frame: Baseline to Day 42 ]
  • Heart Rate Change From Baseline to Day 42 Endpoint [ Time Frame: Baseline, Day 42 ]
  • Temperature Change From Baseline to Day 42 Endpoint [ Time Frame: Baseline, Day 42 ]
  • Blood Pressure Change From Baseline to Day 42 Endpoint [ Time Frame: Baseline, Day 42 ]
  • Weight Change From Baseline to Day 42 Endpoint [ Time Frame: Baseline, Day 42 ]
  • 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 ]
  • 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 ]
  • To assess the safety and tolerability of atomoxetine at each dosage [ Time Frame: Each study visit ]
Not Provided
Not Provided
 
Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 3b, Randomized, Open-Label Assessment of Response to Various Doses of Atomoxetine Hydrochloride in Korean Pediatric Outpatients With Attention-Deficit/Hyperactivity Disorder
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)
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • 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
  • 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
  • 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
  • Active Comparator: Atomoxetine 0.2 milligram per kilogram per day (mg/kg/day)
    Intervention: Drug: Atomoxetine Hydrochloride
  • Active Comparator: Atomoxetine 0.5 mg/kg/day
    Intervention: Drug: Atomoxetine hydrochloride
  • Active Comparator: Atomoxetine 1.2 mg/kg/day
    Intervention: Drug: Atomoxetine hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
150
November 2008
November 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00568685
11710
B4Z-KL-LYEC
No
Not Provided
Not Provided
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP