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Comparison Atomoxetine Hydrochloride and Comparator in Pediatric Outpatients With ADHD

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ClinicalTrials.gov Identifier: NCT00486083
Recruitment Status : Completed
First Posted : June 13, 2007
Last Update Posted : June 13, 2007
Sponsor:
Information provided by:

June 11, 2007
June 13, 2007
June 13, 2007
December 2003
Not Provided
Test the hypothesis that atomoxetine hydrochloride is non-inferior to methylphenidate hydrochloride in improving ADHD symptoms following an approximately 8-week period of double blind treatment as assessed by a comparison of response rates
Same as current
No Changes Posted
  • To compare the tolerability of atomoxetine and methylphenidate as assessed by treatment-emergent adverse events
  • To assess the comparability of the efficacy of atomoxetine and methylphenidate on the Conners' Parent Rating Scale-Revised: Short Form
  • To compare atomoxetine and methylphenidate on other secondary measures
Same as current
Not Provided
Not Provided
 
Comparison Atomoxetine Hydrochloride and Comparator in Pediatric Outpatients With ADHD
A Randomized, Double-Blind Comparison, Safety and Efficacy Trial of Atomoxetine Hydrochloride and Methylphenidate Hydrochloride in Pediatric Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder
The purpose of the study is to compare atomoxetine hydrochloride and methylphenidate hydrochloride in pediatric patients with ADHD.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • Drug: Atomoxetine Hydrochloride
  • Drug: Methylphenidate Hydrochloride
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
330
October 2004
Not Provided

Inclusion Criteria:

  • Be at least 6 years of age and not more than 16 years of age at Visit 1
  • Must meet DSM-IV criteria for ADHD
  • Must be of normal intelligence (that is, without a general impairment of intelligence and likely, in the investigator's judgement, to achieve a score of greater than or equal to 70 on an IQ test)
  • Must be able to swallow capsules
  • Must have laboratory results that show no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation)

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
  • 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 anti-convulsants for seizure control
  • Have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions,including a hypersensitivity to methylphenidate
Sexes Eligible for Study: All
6 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
China,   Korea, Republic of,   Mexico
 
 
NCT00486083
6934
B4Z-MC-LYBR
Not Provided
Not Provided
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