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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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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

Ages Eligible for Study:   13 Years to 16 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Eli Lilly and Company

Additional 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
Study First Received: September 12, 2005
Last Updated: December 12, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013