Long-term 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-jRCT2080222719

Enrollment

170

Registered

2015-01-16

Start date

2015-02-21

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: Continuing participants from Phase 2/3 study: Patient has completed the preceding study (Phase II/III Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder). And et al. New participants: 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 considered a suicide risk. etc.

Design outcomes

Primary

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

Secondary

Measure	Time frame
efficacy ADHD RS-IV, 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