A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine
- Conditions
- Attention-Deficit/Hyperactivity DisorderMedDRA version: 23.0Level: LLTClassification code 10003735Term: Attention deficit-hyperactivity disorderSystem Organ Class: 100000004873Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-000740-18-Outside-EU/EEA
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
•Male or female outpatients between 8 and 11 years of age at study entry
•Attention-Deficit/Hyperactivity Disorder (ADHD) meeting the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) disease diagnostic criteria
•Patients who have never received medications psychotropic medications specifically to treat ADHD, or if they have received medication, that the trial of the psychotropic medication(s) was of less than 1 month duration, and occurred more than 6 months prior to study entry
•Normal intelligence in the judgment of the investigator
•Must be able to swallow capsules
Are the trial subjects under 18? yes
Number of subjects for this age range: 228
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
•Current or past history of bipolar I or II disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or conduct disorder
•History of seizure disorder or currently taking anticonvulsants for seizure control
•Serious suicidal risk as determined by investigator
•Cardiovascular disease; current or past history of hypertension
•Previous treatment with atomoxetine
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method