NCT00485407

Brief Summary

The purpose of this trial is to test the value of dose increases in patients with residual ADHD symptoms after treatment with the usual target dose of atomoxetine

Trial Health

90
On Track

Trial Health Score

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

Enrollment
377

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2003

Geographic Reach
2 countries

2 active sites

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

July 1, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2 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

November 1, 2007

Status Verified

June 1, 2007

First QC Date

June 11, 2007

Last Update Submit

October 31, 2007

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

  • Test whether patients treated with atomoxetine 1.2 mg/kg/day who have sub-optimal clinical responses and peak plasma atomoxetine levels no higher than 800 ng/mL will benefit from a dose increase to 2.4 mg/kg/day

Secondary Outcomes (3)

  • Assess the relationship between plasma atomoxetine concentration levels and ADHD symptom response

  • Compare the efficacy of atomoxetine up to 2.4 mg/kg/day with atomoxetine at 1.2 mg/kg/day in reducing residual ADHD symptoms

  • Assess the safety and tolerability of atomoxetine at doses up to 2.4 mg/kg/day compared to 1.2 mg/kg/day in patients with peak plasma atomoxetine concentration levels no higher than 800 ng/mL as assessed by AEs elicited during open-ended questioning

Interventions

Atomoxetine HydrochlorideDRUG

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Outpatients who are at least 6 years of age and not more than 16 years of age at Visit 1
  • Patients must meet DSM-IV diagnostic criteria for ADHD (any subtype)
  • Patients must have laboratory results showing no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation)
  • Patients must be of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence and likely, in the investigator's judgment, to achieve a score of greater than or equal to 70 on an IQ test)
  • Patients must be able to swallow capsules

You may not qualify if:

  • Patients who weigh less than 25 kg or greater than 70 kg at study entry
  • Patients with current or past Bipolar I or II disorder, psychosis, autism, Asperger's syndrome, or pervasive developmental disorder
  • Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control
  • Patients with a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions
  • Patients with cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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.

Scottsdale, Arizona, United States

Location

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.

Vancouver, British Columbia, Canada

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 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 11, 2007

First Posted

June 13, 2007

Study Start

July 1, 2003

Study Completion

June 1, 2005

Last Updated

November 1, 2007

Record last verified: 2007-06

Locations

US(1)CA(1)