Phase II/III Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222718

Enrollment

Registered

2015-01-16

Start date

2015-01-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention-deficit/Hyperactivity Disorder

Interventions

investigational material(s) Generic name etc : Lisdexamfetamine Mesilate INN of investigational material : Lisdexamfetamine Mesilate Therapeutic category code : 117 Psychotropic agents Dosage and Admi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

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 disease such as schizophrenia spectrum, or bipolar disorder. 3) Patient has personality disorder or mental retardation. 4) Patient considered a suicide risk. etc.

Design outcomes

Primary

Measure	Time frame
efficacy ADHD RS-IV, etc.	—

Secondary

Measure	Time frame
safety The presence or absence of adverse events/reactions and their incidence, etc.	—

Countries

Japan

Contacts

Public ContactContact for Clinical Trial Information

Takeda Pharmaceutical Company Limited

smb.Japanclinicalstudydisclosure@takeda.com+81-6-6204-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026