Phase II/III Study of S-877503 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Registration Number
- JPRN-jRCT2080222070
- Lead Sponsor
- SHIONOGI & CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
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]). And et al.
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, bipolar disorder, and pervasive
developmental disorder.
3) Patient has personality disorder or mental retardation.
4) Patient is orthostatic hypotensive or hypertensive.
5) Patient had a documented allergy, hypersensitivity or intolerance to guanfacine
hydrocholoride.
6) Patient considered a suicide risk. And et al.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of S-877503 in the treatment of Attention-deficit/hyperactivity Disorder
- Secondary Outcome Measures
Name Time Method