Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00485459
First received: June 11, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

June 11, 2007
June 11, 2007
February 2004
Not Provided
Test the hypothesis that atomoxetine administered as a single-daily dose provides superior efficacy compared with placebo in Taiwanese children and adolescents with ADHD
Same as current
No Changes Posted
  • Compare the improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo
  • Compare the reduction in school-related symptoms between atomoxetine and placebo
  • Assess the safety and tolerability of once-daily dosing of atomoxetine
Same as current
Not Provided
Not Provided
 
Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD
Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With Attention-Deficit/Hyperactivity Disorder

The purpose of this protocol is to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and adolescents with ADHD.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • Drug: Atomoxetine Hydrochloride
  • Drug: Placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
November 2004
Not Provided

Inclusion Criteria:

  • Subject must have ADHD that meet DSM-IV disease diagnostic criteria as well as severity criteria
  • Subjects must be aged 6 to 16 years
  • Subjects must not have taken any medication used to treat ADHD or they must have completed the washout procedures
  • Subjects must be able to swallow capsules
  • Subjects must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 80 or more if formal IQ testing were administered.

Exclusion Criteria:

  • Weigh less than 20 kg or more than 60 kg at study entry
  • Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder
  • Meet DSM-IV criteria for an anxiety disorder as assessed by the investigator
  • Have a history of any seizure disorder (other than febrile seizures) or prior ECG abnormalities related to epilepsy, or subjects who have taken (or are currently taking) anticonvulsants for seizure control
  • Subjects who have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
Both
6 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00485459
8160, B4Z-TW-S010
Not Provided
Not Provided
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
June 2007

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