Status:
COMPLETED
An Open-Label Study of Atomoxetine in Adolescents With Attention-Deficit/Hyperactivity Disorder
Lead Sponsor:
Eli Lilly and Company
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
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 p...
Eligibility Criteria
Inclusion
- Male or female outpatients who are at least 12 years of age and who will not have reached their 18th birthday
- Diagnosis of ADHD
- Normal intelligence
Exclusion
- Weigh less than 30 kg or more than 85 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
- Are female patients who are pregnant or breast-feeding. Sexually active females must use a medically acceptable method of contraception.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00191737
Start Date
October 1 2004
End Date
February 1 2006
Last Update
January 26 2007
Active Locations (2)
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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.
Cologne, Germany
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.
Freiburg im Breisgau, Germany