|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00191516 |
|
Date of registration:
|
12/09/2005 |
|
Primary sponsor: |
|
|
Public title:
|
An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder
|
|
Scientific 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 |
|
Date of first enrolment:
|
October 2004 |
|
Target sample size:
|
257 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00191516 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
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) |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Eli Lilly and Company |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
6 Years
Age maximum:
11 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Attention Deficit Hyperactivity Disorder
|
|
Intervention(s)
|
|
Drug: Atomoxetine
|
|
Primary Outcome(s)
|
|
Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24
|
|
Secondary Outcome(s)
|
|
O'Brien Sleep Questionnaire during 8 and 24 weeks of treatment
|
|
Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment.
|
|
Secondary ID(s)
|
|
9496
|
|
B4Z-SB-LYDD
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|