Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00568685
First received: December 4, 2007
Last updated: January 19, 2010
Last verified: January 2010
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Purpose
The purpose of this study is to provide information regarding the relative effectiveness of three different atomoxetine doses in the treatment of Korean children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD)
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: Atomoxetine Hydrochloride Drug: Atomoxetine hydrochloride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3b, Randomized, Open-Label Assessment of Response to Various Doses of Atomoxetine Hydrochloride in Korean Pediatric Outpatients With Attention-Deficit/Hyperactivity Disorder |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score [ Time Frame: Baseline, Day 42 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint [ Time Frame: Baseline, Days 7, 14, 42 ] [ Designated as safety issue: No ]
- Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint [ Time Frame: Baseline, Days 7, 14, 42 ] [ Designated as safety issue: No ]
- Adverse Events Leading to Discontinuation [ Time Frame: Baseline to Day 42 ] [ Designated as safety issue: Yes ]
- Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary [ Time Frame: Baseline to Day 42 ] [ Designated as safety issue: Yes ]
- Heart Rate Change From Baseline to Day 42 Endpoint [ Time Frame: Baseline, Day 42 ] [ Designated as safety issue: No ]
- Temperature Change From Baseline to Day 42 Endpoint [ Time Frame: Baseline, Day 42 ] [ Designated as safety issue: No ]
- Blood Pressure Change From Baseline to Day 42 Endpoint [ Time Frame: Baseline, Day 42 ] [ Designated as safety issue: No ]
- Weight Change From Baseline to Day 42 Endpoint [ Time Frame: Baseline, Day 42 ] [ Designated as safety issue: No ]
| Enrollment: | 153 |
| Study Start Date: | November 2007 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Atomoxetine 0.2 milligram per kilogram per day (mg/kg/day) |
Drug: Atomoxetine Hydrochloride
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period
Other Names:
|
| Active Comparator: Atomoxetine 0.5 mg/kg/day |
Drug: Atomoxetine hydrochloride
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period
Other Names:
|
| Active Comparator: Atomoxetine 1.2 mg/kg/day |
Drug: Atomoxetine hydrochloride
Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days Other Names:
|
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients will be outpatients who are aged 6 to 18 years old at the initial screening visit.
- Patients must have ADHD, based on the accepted criteria for that disease
- Patients must not have taken any medication used to treat ADHD for at least two weeks prior to beginning study treatment; and at least one week prior to the study screening visit during which initial ADHD assessments were made
- Patients must be able to swallow capsules
- Patients and parents (or legal guardians) must be judged by the study investigator to be reliable to keep appointments for clinic visits and all tests, including blood tests and any other required examinations
Exclusion Criteria:
- Patients must not have received any treatment within the last 30 days with a drug that has not been approved by their country's appropriate government agency
- Patients will not be included in the study if they have previously experienced any unwanted effects or serious medical events during atomoxetine treatment
- Patients will not be included in the study if they are judged by the study investigator to be at serious suicidal risk
- Patients will not be included in the study if they have cardiovascular disease or other conditions that could be worsened by an increased heart rate or increased blood pressure
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568685
Locations
| Korea, Republic of | |
| 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. | |
| Bucheon, Korea, Republic of, 420-767 | |
| 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. | |
| In Cheon, Korea, Republic of, 405-760 | |
| 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. | |
| Seoul, Korea, Republic of, 135-720 | |
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
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00568685 History of Changes |
| Other Study ID Numbers: | 11710, B4Z-KL-LYEC |
| Study First Received: | December 4, 2007 |
| Results First Received: | November 11, 2009 |
| Last Updated: | January 19, 2010 |
| Health Authority: | Korea: 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 |
Atomoxetine Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013