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| Sponsored by: |
Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00700427 |
Purpose
LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive under open label conditions atomoxetine up to 100 mg/day during the acute, open label part of the study. Those patients that meet the response criteria will continue the blind phase of the study up to a year. During that period patients that respond to atomoxetine will be randomized to continue the treatment with atomoxetine or with placebo (neither the patients or investigators know if patients receive atomoxetine or placebo).
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: atomoxetine hydrochloride Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Maintenance of Response After Open-Label Treatment With Atomoxetine Hydrochloride in Adult Outpatients With Attention-Deficit/Hyperactivity Disorder (ADHD): A Placebo-Controlled, Randomized Withdrawal Study |
| Estimated Enrollment: | 1925 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Atomoxetine, 40-100 mg/day, QD or BID, 12 weeks followed by atomoxetine, 80-100 mg/day, QD or BID, 37 weeks
|
Drug: atomoxetine hydrochloride |
|
2: Placebo Comparator
Atomoxetine, 40-100 mg/day, QD or BID, 12 weeks followed by placebo, oral, daily, 37 weeks
|
Drug: atomoxetine hydrochloride Drug: placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: There may be multiple sites in the clinical trial 1-877-CTLILLY (1-877-285-4559), or | 1-317-615-4559 |
Show 136 Study Locations| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5hours, EST) | Eli Lilly and Company |
More Information
| Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
| Study ID Numbers: | 9655, B4Z-MC-LYDO |
| Study First Received: | June 16, 2008 |
| Last Updated: | June 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00700427 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
ADHD Adult long term maintenance of response Attention Deficit Hyperactivity Disorder |
|
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 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 |
