Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHD

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Lilly

Status and phase

Completed
Phase 4

Conditions

Attention-Deficit/Hyperactivity Disorder
Comorbid Dyslexia

Treatments

Drug: Atomoxetine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00191048
B4Z-US-LYCE
7975

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of atomoxetine administered once daily in the treatment of children and adolescents with ADHD and comorbid dyslexia.

Sex

All

Ages

10 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with ADHD only or ADHD and Dyslexia
  • At least 10 years old and no more than 16 years old
  • IQ score of 80 or more
  • Must be able to swallow capsules

Exclusion criteria

  • Have received treatment within last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
  • Weigh less than 25 kg or greater than 70 kg
  • Pregnant or breast feeding
  • Documented history of bipolar I or II disorder, or psychosis
  • Documented history of autism, Asperger's syndrome or pervasive developmental disorder

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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