Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Eli Lilly and Company |
---|---|
Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00191698 |
The purpose of this trial is to test the effectiveness of atomoxetine in treating symptoms of ODD in children with ADHD and ODD.
Condition | Intervention | Phase |
---|---|---|
Attention Deficit Hyperactivity Disorder Oppositional Defiant Disorder |
Drug: atomoxetine hydrochloride Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride and Placebo in Child and Adolescent Outpatients With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder |
Enrollment: | 226 |
Study Start Date: | December 2003 |
Study Completion Date: | November 2007 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Atomoxetine is administered at 1.2 mg/kg/day, PO for 8 weeks, followed by 1.2 or 2.4 mg/kg/day, PO for 4 weeks, open label administration can continue for up to one year
|
Drug: atomoxetine hydrochloride |
B: Placebo Comparator
Placebo is administered by mouth, daily for 8 weeks. After 8 weeks, those randomized to placebo may be titrated to 1.2 mg/kg/day atomoxetine for the remainder of the study up to one year
|
Drug: placebo |
Ages Eligible for Study: | 6 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Australia, New South Wales | |
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
Wallsend, New South Wales, Australia, 2287 | |
Australia, Victoria | |
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
Parkville, Victoria, Australia, 3052 | |
Belgium | |
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
Leuven, Belgium, 3000 | |
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
Antwerpen, Belgium, 2020 | |
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
Brussels, Belgium, 1200 | |
Denmark | |
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
Risskov, Denmark, 8240 | |
Finland | |
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
Helsinki, Finland, 00290 | |
Germany | |
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
Mannheim, Germany, 68159 | |
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
Ulm, Germany, D-89075 | |
Netherlands | |
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
Utrecht, Netherlands, 3584 CS | |
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
Nijmegen, Netherlands, 6500 HB | |
Spain | |
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
Barcelona, Spain, 08035 | |
Spain, Barcelona | |
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
Tarrasa, Barcelona, Spain | |
Spain, Navarra | |
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
Pamplona, Navarra, Spain, 31008 | |
United Kingdom | |
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
Edinburgh, United Kingdom, EH9 1LL | |
United Kingdom, Augus | |
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
Dundee, Augus, United Kingdom, DD36HH |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 7068, B4Z-MC-LYBX |
Study First Received: | September 12, 2005 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00191698 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Signs and Symptoms Neurotransmitter Agents Adrenergic Agents Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood |
Atomoxetine Neurologic Manifestations Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Oppositional Defiant Disorder Dyskinesias |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Atomoxetine |
Dyskinesias Pharmacologic Actions Signs and Symptoms Pathologic Processes Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations |