NCT00485628

Brief Summary

Evaluate the safety and efficacy of atomoxetine in Japanese pediatric patients with ADHD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2007

Completed
Last Updated

June 13, 2007

Status Verified

June 1, 2007

First QC Date

June 11, 2007

Last Update Submit

June 11, 2007

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

  • The primary objective of the study is to assess whether treatment with 1.8 mg/kg/day of atomoxetine will be safe and tolerable in a population of Japanese pediatric patients aged 6 through 18 years.

Secondary Outcomes (2)

  • To investigate the symptom scores in the ADHDRS-J at baseline and with atomoxetine therapy.

  • To evaluate the plasma concentration of atomoxetine, 4-hydroxyatomoxetine and N-desmethylatomoxetine

Interventions

Atomoxetine HydrochlorideDRUG

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients must be 6 - 18 years of age
  • Patients must meet DSM-IV diagnostic criteria for ADHD
  • Patient must be able to swallow capsules
  • Patients must be of normal intelligence
  • Laboratory results must show no significant abnormalities

You may not qualify if:

  • Patients who weigh less than 15 kg or more than 75 kg at study entry
  • Patients who have a documented history of bipolar disorder or any history of psychosis
  • Patients taking any antipsychotic medication within 26 weeks of visit 1
  • Patients with a severe history of allergies
  • Patients taking methylphenidate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tokyo, Japan

Location

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 11, 2007

First Posted

June 13, 2007

Study Start

April 1, 2003

Study Completion

October 1, 2003

Last Updated

June 13, 2007

Record last verified: 2007-06

Locations

JP(1)