Phase III Study of S-877503 in Adult Patients with Attention-deficit/Hyperactivity Disorder
Phase 3
Completed
- Conditions
- Attention-deficit/hyperactivity disorder
- Registration Number
- JPRN-jRCT2080223176
- Lead Sponsor
- Shionogi & Co., Ltd.
- Brief Summary
S-877503 tablets were administered to ADHD patients aged 18 years or older. Administration of S-877503 statistically significantly improved the symptoms of ADHD compared with placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 201
Inclusion Criteria
Patient meets the DSM-5 criteria for a primary diagnosis of ADHD currently and during his/her childhood, etc.
Exclusion Criteria
Patient has complications such as serious hepatic disorder, renal disorder, heart disease, lung disease, hematological disease, and metabolic disease.
Patient has psychiatric disease such as schizophrenia spectrum disorder and bipolar disorder.
Patient has personality disorder or intellectual capacity disorder.
Patient is orthostatic hypotensive.
Patient has persistent bradycardia.
Patient has suicidal tendency. etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Change from baseline in the ADHD-RS IV with adult prompts (Japanese version) at Week 10
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>CAARS (Japanese version), etc.