Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder
Intervention: Atomoxetine Hydrochloride (Drug); Atomoxetine hydrochloride (Drug); Atomoxetine hydrochloride (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): 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), Study Director, Affiliation: Eli Lilly and Company
Summary
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)
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: 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 EndpointChange 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 Adverse Events Leading to Discontinuation Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary Heart Rate Change From Baseline to Day 42 Endpoint Temperature Change From Baseline to Day 42 Endpoint Blood Pressure Change From Baseline to Day 42 Endpoint Weight Change From Baseline to Day 42 Endpoint
Eligibility
Minimum age: 6 Years.
Maximum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
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 420-767, 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., In Cheon 405-760, 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., Seoul 135-720, Korea, Republic of
Additional Information
Lilly Clinical Trial Registry
Starting date: November 2007
Last updated: January 19, 2010
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