Phase II/III Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Registration Number
- JPRN-jRCT2080222718
- Lead Sponsor
- Shionogi & Co., Ltd.
- Brief Summary
The superiority of 4 week-administration of S-877489 at the doses of 30, 50, and 70 mg versus the placebo was verified from the above results, and thus the efficacy of S-877489 in pediatric patients with ADHD was demonstrated. It was considered that there might be no great safety concerns, because neither serious nor severe adverse events and no adverse events specific to Japanese subjects occurred.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 76
1) Patient aged from 6 to 17 years at the time of signing the informed consent form.
2) Patient meets the DSM-5 criteria for a principal diagnosis of ADHD (combined presentation [314.01], predominantly inattentive presentation [314.00], or predominantly hyperactive-impulsive presentation [314.01]). etc.
1) Patient has complications such as serious hepatic disorder, renal disorder, heart disease, lung disease, hematological disease, and metabolic disease.
2) Patient has psychiatric disease such as schizophrenia spectrum, or bipolar disorder.
3) Patient has personality disorder or mental retardation.
4) Patient considered a suicide risk.
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>ADHD RS-IV, etc.
- Secondary Outcome Measures
Name Time Method safety<br>The presence or absence of adverse events/reactions and their incidence, etc.