Attention-Deficit/Hyperactivity Disorder (ADHD) MedDRA version: 23.0 Level: LLT Classification code 10003735 Term: Attention deficit-hyperactivity disorder System Organ Class: 100000004873
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? yes Number of subjects for this age range: 153 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess graphically dose-response with atomoxetine, as measured by change from baseline to endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) total score ;Secondary Objective: To measure: a) Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) b) Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) c) Adverse Events Leading to Discontinuation d) Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary e) Heart Rate Change f) Temperature Change g) Blood Pressure Change h) Weight Change ;Primary end point(s): 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);Timepoint(s) of evaluation of this end point: Baseline, Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) b) Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) c) Adverse Events Leading to Discontinuation d) Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary e) Heart Rate Change f) Temperature Change g) Blood Pressure Change h) Weight Change ;Timepoint(s) of evaluation of this end point: a) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint b) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint c-h) Baseline to Day 42 | — |
Countries
Korea, Republic of
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed