Back to resultsComparison of Atomoxetine Plus Either Comparator or Placebo in Children With ADHD Who Haven't Responded to Stimulant Therapy
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine Hydrochloride
Methylphenidate Hydrochloride
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder
Eligibility 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
Sites / Locations
- 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.
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00485550
Brief Title
Comparison of Atomoxetine Plus Either Comparator or Placebo in Children With ADHD Who Haven't Responded to Stimulant Therapy
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atomoxetine Hydrochloride
Intervention Type
Drug
Intervention Name(s)
Methylphenidate Hydrochloride
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
Compare the efficacy of atomoxetine and placebo as compared to atomoxetine and methylphenidate for the treatment of ADHD in children
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Scottsdale
State/Province
Arizona
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Atomoxetine Plus Either Comparator or Placebo in Children With ADHD Who Haven't Responded to Stimulant Therapy
We'll reach out to this number within 24 hrs