Clinical trial NCT00568685: Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-12-06
Enrollment: 153
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Baseline, Day 42
Secondary outcomes:
measure: 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
timeFrame: Baseline, Days 7, 14, 42
measure: 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
timeFrame: Baseline, Days 7, 14, 42
measure: Adverse Events Leading to Discontinuation
timeFrame: Baseline to Day 42
measure: Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary
timeFrame: Baseline to Day 42
measure: Heart Rate Change From Baseline to Day 42 Endpoint
timeFrame: Baseline, Day 42
measure: Temperature Change From Baseline to Day 42 Endpoint
timeFrame: Baseline, Day 42
measure: Blood Pressure Change From Baseline to Day 42 Endpoint
timeFrame: Baseline, Day 42
measure: Weight Change From Baseline to Day 42 Endpoint
timeFrame: Baseline, Day 42
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: 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: In Cheon
country: Korea, Republic of
facility: 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: Seoul
country: Korea, Republic of
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: