Phase III Study of S-877503 in Adult Patients with ADHD -long term extension study
Phase 3
Completed
- Conditions
- Attention-deficit/hyperactivity disorder
- Registration Number
- JPRN-jRCT2080223177
- Lead Sponsor
- Shionogi & Co., Ltd.
- Brief Summary
ong-term administration of S-877503 poses no serious safety concern and suggested that the efficacy was sustained in ADHD patients aged 18 years or more.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 191
Inclusion Criteria
Patient has completed 12-week administration in the preceding study of S-877503 in adult with ADHD, etc.
Exclusion Criteria
Patient has complications such as serious hepatic disorder, renal disorder, heart disease, lung disease, hematological disease, and metabolic disease.
Patient has suicidal tendency. etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Percentage of patients with any adverse events, etc.
- Secondary Outcome Measures
Name Time Method efficacy<br>ADHD-RS IV with adult prompts (Japanese version), etc.