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Intuniv Tablets drug use-results survey (Surveillance regarding pediatric use)

Intuniv Tablets drug use-results survey (Surveillance regarding pediatric use)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1080223870
Enrollment
75
Registered
2018-04-16
Start date
2018-05-01
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 : Intuniv Tablets (Guanfacine) INN of investigational material : guanfacine Therapeutic category code : 117 Psychotropic agents Dosage and Administration f
Body weight 17 kg <= to <25 kg : 1 mg-1 mg-2 mg, 25 kg <= to <34 kg : 1 mg-2 mg-3 mg, 34 kg <= to <38 kg : 1 mg-2 mg-4 mg, 38 kg <= to <42 kg : 1 mg-3 mg-4 mg, 42 kg <= to <50 kg : 1 mg-3 mg-5 mg, 50

Sponsors

SHIONOGI & CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with attention deficit/hyperactivity disorder (AD/HD) who fulfill the following criteria will be included in the surveillance. Inclusion criteria 1. Subject has no experience of using Study Drug. 2. Subject is from 6 to under 18 years old (as of starting Study Drug administration). (The investigation will be continued when the subjects become over the age of 18 during the observation period.) 3. Subject has no experience of using other AD/HD drugs for 14 days before starting Study Drug administration (except the date of starting Study Drug administration). 4. Subject has the teacher's and physician's evaluation score by the ADHD RS-IV before starting Study Drug administration.

Exclusion criteria

Exclusion criteria: -

Design outcomes

Primary

MeasureTime frame
safety efficacy Safety, Efficacy ADHD RS-IV

Secondary

MeasureTime frame
other -

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