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| Sponsor: | Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00922636 |
Purpose
The primary purpose of your child's participation in this study is to determine whether LY2216684 can help pediatric patients with ADHD; and assess the safety of LY2216684 and any side effects that might be associated with it.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: LY2216684 Drug: Methylphenidate Drug: Placebo (tablet) Drug: Placebo (capsule) |
Phase II 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: | A Fixed-Dose, Randomized, Double-Blind, Placebo-Controlled Study of LY2216684 in Pediatric Patients With Attention Deficit/Hyperactivity Disorder |
| Estimated Enrollment: | 270 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Methylphenidate: Active Comparator |
Drug: Methylphenidate
Extended-release methylphenidate 18 mg/day to 54 mg/day, based on weight, given once daily and orally as a capsule for 10 weeks.
|
| Placebo: Placebo Comparator |
Drug: Placebo (tablet)
Placebo given once daily and orally for 10 weeks as a tablet for LY2416684 blind.
Drug: Placebo (capsule)
Placebo given once daily and orally for 10 weeks as a capsule for methylphenidate blind.
|
| LY2216684 (0.1 mg/kg/day): Experimental |
Drug: LY2216684
Taken by mouth once daily for 10 weeks.
|
| LY2216684 (0.2 mg/kg/day): Experimental |
Drug: LY2216684
Taken by mouth once daily for 10 weeks.
|
| LY2216684 (0.3 mg/kg/day): Experimental |
Drug: LY2216684
Taken by mouth once daily for 10 weeks.
|
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
Show 36 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 - 5 hours, EST) | Eli Lilly and Company |
More Information
| Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
| Study ID Numbers: | 10925, H9P-MC-LNBF |
| Study First Received: | June 16, 2009 |
| Last Updated: | January 15, 2010 |
| ClinicalTrials.gov Identifier: | NCT00922636 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Mexico: Ethics Committee; Mexico: Ministry of Health; Taiwan: Department of Health; Taiwan: Institutional Review Board |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Methylphenidate Central Nervous System Stimulants Dyskinesias |
Pharmacologic Actions Signs and Symptoms Pathologic Processes Attention Deficit Disorder with Hyperactivity Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations Dopamine Agents Central Nervous System Agents |