Clincosm LogoSign in Get a demo

An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00191516
Collaborator
(none)
257
Enrollment
1
Location
16
Duration (Months)
16
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by patients, parents and physicians, and its impact on quality of sleep in children (aged 6 through 11 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in Germany. An 8-week treatment phase is followed by a 16-week extension period.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Study on Effectiveness and Tolerability of Atomoxetine as Perceived by Patients, Parents, and Physicians in Children With Attention-Deficit/Hyperactivity Disorder in Germany
Study Start Date :
Oct 1, 2004
Study Completion Date :
Feb 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24 []

Secondary Outcome Measures

  1. Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment. []

  2. O'Brien Sleep Questionnaire during 8 and 24 weeks of treatment []

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 11 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male or female outpatients who are at least 6 years of age and who will not have reached their 12th birthday

  • Diagnosis of ADHD

  • Normal intelligence

Exclusion Criteria:

  • Weigh less than 20 kg or more than 60 kg at study entry

  • Other relevant psychiatric diagnoses

  • Are at serious suicidal risk as determined by the investigator

  • Have a history of severe allergies

  • Alcohol or drug abuse within the past 3 months

Contacts and Locations

Locations

Site City State Country Postal Code
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. Koln Germany D-50931

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Chair: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00191516
Other Study ID Numbers:
  • 9496
  • B4Z-SB-LYDD
First Posted:
Sep 19, 2005
Last Update Posted:
Jan 26, 2007
Last Verified:
Jan 1, 2007
Additional relevant MeSH terms:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Atomoxetine Hydrochloride

Study Results

No Results Posted as of Jan 26, 2007