A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00471354
First received: May 7, 2007
Last updated: January 4, 2010
Last verified: January 2010

May 7, 2007
January 4, 2010
April 2007
November 2008   (final data collection date for primary outcome measure)
Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline (premedicated) to 24 weeks in ADHD symptoms as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) total score. [ Time Frame: Baseline (premedicated) to 24 weeks post-treatment ]
  • Change from baseline in academic performance of medication naive patients treated with atomoxetine at 24 weeks as measured by School Grade Average. [ Time Frame: Baseline (premedicated) and 16 - 24 weeks post-treatment ]
Complete list of historical versions of study NCT00471354 on ClinicalTrials.gov Archive Site
  • Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 24 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • CGI-ADHD-Improvement Scale (CGI-ADHD-I) at 24 Week Endpoint [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 24 Week Endpoint in Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S) Attention-Deficit/Hyperactivity Disorder Index Score [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in ADHD symptoms as measured by the total score of the Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S). [ Time Frame: Baseline (premedicated) to 24 weeks post-treatment ]
  • Change in ADHD symptoms, as measured by the total score of the CGI-ADHD-Improvement Scale (CGI-ADHD-I) at 24 weeks. [ Time Frame: Baseline (premedicated) to 24 weeks post-treatment ]
  • Change from baseline to 24 weeks in ADHD symptoms, as measured by the Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S). [ Time Frame: Baseline (premedicated) to 24 weeks post-treatment ]
Not Provided
Not Provided
 
A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine
Evaluation of Academic Performance in Asian Children Aged 8 to 11 Years With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine Hydrochloride

The purpose of the study is to investigate the relationship of changes in measures of academic performance and problem behaviors, to changes in core Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in Asian children treated with atomoxetine.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
Drug: Atomoxetine
atomoxetine 0.5 mg/kg/day once a day (QD), by mouth (PO) starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
Other Names:
  • LY139603
  • Strattera
Experimental: Atomoxetine
0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
Intervention: Drug: Atomoxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
228
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female outpatients between 8 and 11 years of age at study entry
  • Attention-Deficit/Hyperactivity Disorder (ADHD) meeting the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) disease diagnostic criteria
  • Patients who have never received medications psychotropic medications specifically to treat ADHD, or if they have received medication, that the trial of the psychotropic medication(s) was of less than 1 month duration, and occurred more than 6 months prior to study entry
  • Normal intelligence in the judgment of the investigator
  • Must be able to swallow capsules

Exclusion Criteria:

  • Current or past history of bipolar I or II disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or conduct disorder
  • History of seizure disorder or currently taking anticonvulsants for seizure control
  • Serious suicidal risk as determined by investigator
  • Cardiovascular disease; current or past history of hypertension
  • Previous treatment with atomoxetine
Both
8 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
China,   Korea, Republic of,   Taiwan
 
NCT00471354
11098, B4Z-CR-S018
No
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