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

Attention Deficit Hyperactivity Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191516
• Other study ID #: 9496
• Secondary ID: B4Z-SB-LYDD
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: January 24, 2007
• Start date: October 2004
• Est. completion date: February 2006

Study information

• Verified date: January 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Atomoxetine

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24
Secondary	Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment.
Secondary	O'Brien Sleep Questionnaire during 8 and 24 weeks of treatment