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Maintenance of Benefit With Atomoxetine Hydrochloride in Adolescents With ADHD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00191035
First Posted: September 19, 2005
Last Update Posted: December 13, 2006
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.
Information provided by:
Eli Lilly and Company
  Purpose
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

Condition Intervention Phase
Attention-Deficit/Hyperactivity Disorder Drug: Atomoxetine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Maintenance of Benefit After 8-Week and 52-Week Treatment With Atomoxetine Hydrochloride in Adolescents With ADHD

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 520
Study Start Date: March 2004
Estimated Study Completion Date: November 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00191035


  Show 21 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00191035     History of Changes
Other Study ID Numbers: 7974
B4Z-US-LYCD
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: December 13, 2006
Last Verified: December 2006

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs