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Maintenance of Benefit With Atomoxetine Hydrochloride in Adolescents With ADHD

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191035
First received: September 12, 2005
Last updated: December 12, 2006
Last verified: December 2006

September 12, 2005
December 12, 2006
March 2004
Not Provided
Assess the difference in maintenance of response at 52 weeks between atomoxetine dosed at 0.8mg/kg/day vs.1.4 mg/kg/day measured by ADHDRS-IV-Parent:Inv
Same as current
Complete list of historical versions of study NCT00191035 on ClinicalTrials.gov Archive Site
Assess the relationship between different dosing titrations & tolerability at 4 wks, & efficacy at 8 wks; effect of atomoxetine on adaptive,family functioning, academic performance, GPA, health status,health risk behaviors at 8 wks & 52 wks
Same as current
Not Provided
Not Provided
 
Maintenance of Benefit With Atomoxetine Hydrochloride in Adolescents With ADHD
Maintenance of Benefit After 8-Week and 52-Week Treatment With Atomoxetine Hydrochloride in Adolescents With ADHD

The purpose of this study is to assess the efficacy, safety and tolerability of atomoxetine administered once daily in the treatment of adolescents with ADHD after 8 weeks and after 52 weeks

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Attention-Deficit/Hyperactivity Disorder
Drug: Atomoxetine
Not Provided
Wietecha LA, Williams DW, Herbert M, Melmed RD, Greenbaum M, Schuh K. Atomoxetine treatment in adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2009 Dec;19(6):719-30. doi: 10.1089/cap.2008.074.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
520
November 2006
Not Provided

Inclusion Criteria:

  • Patients must have ADHD.
  • Must be 13-16 years of age.
  • Must be able to swallow capsules.
  • Expected to achieve score of 70 or more on IQ test
  • Willing and reliable to keep appts. for clinic visits and test

Exclusion Criteria:

  • Treatment within last 30 days with a drug that has not received regulatory approval for any indication.
  • Patients who weigh less than 40 kg or greater than 70 kg.
  • Patients with documented history of Bipolar I or II disorder, or psychosis
  • Patients with documented history of autism, asperger's syndrome or pervasive developmental disorder
Both
13 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00191035
7974, B4Z-US-LYCD
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
December 2006

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