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Maintenance of Benefit With Atomoxetine Hydrochloride in Adolescents With ADHD

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Lilly

Status and phase

Completed
Phase 4

Conditions

Attention-Deficit/Hyperactivity Disorder

Treatments

Drug: Atomoxetine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00191035
7974
B4Z-US-LYCD

Details and patient eligibility

About

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

Sex

All

Ages

13 to 16 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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