Attention-deficit/Hyperactivity Disorder
Conditions
Sponsors
SHIONOGI & CO., LTD.
Shire Development LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient aged 6 years or older to less than 18 years at the time of signing the informed consent form. 2) Patient meets the DSM-IV-TR criteria for a primary diagnosis of ADHD (predominantly inattentive type [314.00], predominantly hyperactive-impulsive type [314.01], and combined type [314.01]). etc.
Exclusion criteria
Exclusion criteria: 1) Patient has complications such as serious hepatic disorder, renal disorder, heart disease, lung disease, hematological disease, and metabolic disease. 2) Patient has psychiatric disorder such as schizophrenia, bipolar disorder, and pervasive development disorder. 3) Patient has personality disorder or mental retardation. 4) Patient has a documented allergy, hypersensitivity or intolerance to amphetamine. 5) Patient considered a suicide risk. etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety The presence or absence of adverse events/reactions and their incidence, etc. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy ADHD RS-IV, etc. | — |
Countries
Japan
Contacts
Public ContactContact for Clinical Trial Information
Takeda Pharmaceutical Company Limited
Outcome results
None listed