Comparison of Atomoxetine Plus Either Comparator or Placebo in Children With ADHD Who Haven't Responded to Stimulant Therapy
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00485550
First received: June 11, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
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Purpose
The purpose of this study is to evaluate the safety and tolerability of atomoxetine alone versus atomoxetine plus low-dose, sustained-release MPH in children with treatment-resistant ADHD.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: Atomoxetine Hydrochloride Drug: Methylphenidate Hydrochloride Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride Augmented With Either Extended-Release Methylphenidate Hydrochloride (Concerta-TM) or Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) Who Have Not Responded to Stimulant Mono Therapy |
Resource links provided by NLM:
MedlinePlus related topics:
Attention Deficit Hyperactivity Disorder
Drug Information available for:
Methylphenidate
Methylphenidate hydrochloride
Atomoxetine hydrochloride
Atomoxetine
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Assess the safety of atomoxetine and placebo compared to atomoxetine and methylphenidate in children aged 6 through 12 years with ADHD who have been identified as stimulant non-responders and have been exposed to acute treatment of atomoxetine.
Secondary Outcome Measures:
- Assess the safety of atomoxetine and placebo as compared to atomoxetine and methylphenidate for the treatment of ADHD in children retrospectively identified as stimulant non-responders as measured by ECGs
- Assess the safety of atomoxetine and placebo as compared to atomoxetine and methylphenidate for the treatment of ADHD in children retrospectively identified as stimulant non-responders as measured by clinical laboratory tests
- Assess the tolerability of atomoxetine and placebo as compared to atomoxetine and methylphenidate for the treatment of ADHD in children retrospectively identified as stimulant non-responders as measured by spontaneously reported AEs
- Compare the efficacy of atomoxetine and placebo as compared to atomoxetine and methylphenidate for the treatment of ADHD in children
| Enrollment: | 14 |
| Study Start Date: | January 2004 |
| Study Completion Date: | March 2005 |
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients will be at least 6 years of age and not more than 12 years of age at visit 1
- Patients must meet DSM-IV diagnostic criteria for ADHD
- Patients must be retrospectively identified as stimulant non-responders
- Patients must be of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence and likely, in the investigator's judgment, to achieve a score of greater than or equal to 70 on an IQ test)
- Patients must be able to swallow capsules
Exclusion Criteria:
- Patients who weigh less than 22 kg or more than 60 kg at study entry
- Patients who have a history of Bipolar I or Bipolar II Disorder, psychosis, or pervasive developmental disorder
- Patients who meet DSM-IV criteria for anxiety disorder or autism
- Patients with a history of any seizure disorder and/or Rolandic seizures (other than febrile seizures) or prior electroencephalogram (ECG) abnormalities in the absence of seizures, or patients who have taken (or are currently taking) anticonvulsants for seizure control
- Patients with a history of severe allergies to more than one class of medication or multiple adverse drug reactions, including hypersensitivity to MPH
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485550
Locations
| United States, Arizona | |
| 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. | |
| Scottsdale, Arizona, United States | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| 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
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00485550 History of Changes |
| Other Study ID Numbers: | 7065, B4Z-MC-LYBU |
| Study First Received: | June 11, 2007 |
| Last Updated: | June 11, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Methylphenidate Atomoxetine Dopamine Uptake Inhibitors |
Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Uptake Inhibitors Adrenergic Agents |
ClinicalTrials.gov processed this record on May 16, 2013