A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD) : A Phase 4, Multicenter, 2-part Study Composed of a 1-Year Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-comparator, Dose-optimization Evaluation Followed by a 1-Year Open-label Evaluation to Assess the Safety and Efficacy of Guanfacine Hydrochloride Prolonged-release (SPD503) in Children and Adolescents Aged 6 to 17 Years With Attention-deficit/Hyperactivity Disorder

This study will be conducted in two parts Part A and Part B. Part A is a double-blinded, double-dummy, placebo-controlled study with an atomoxetine arm as an active reference to TAK-503. Eligible participants with ADHD will be randomized in a 1:1:1 ratio among TAK-503, atomoxetine, and placebo treatment arms for the first 18 weeks of double-blinded treatment. At the end of the first 18 weeks, participants in the placebo treatment arm will rollover to Part B of the study directly for an additional 52 weeks of open-label TAK-503 treatment. Participants in the TAK-503 and atomoxetine treatment arms will continue in Part A at the same optimized dose for the remainder of the 52 weeks. At the end of 52 weeks of double-blinded treatment and evaluation in Part A, participants in the TAK-503 and atomoxetine treatment arms will rollover into Part B of the study for an additional 1 year of open-label TAK-503 treatment.26 JUNE 2020: The temporary enrollment stop of new participants into this study due to the COVID-19 pandemic has been lifted in one or more countries/sites, and the study is now again enrolling new participants. However, some countries/sites may still have paused the enrollment of new participants due to the pandemic.20 APRIL 2020: Enrollment of new participants into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic..

Medienart:	Klinische Studie

Erscheinungsjahr:	2023
Erschienen:	2023

Enthalten in:	ClinicalTrials.gov - (2023) vom: 07. Juni Zur Gesamtaufnahme - year:2023

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Attention Deficit Disorder with Hyperactivity Hyperkinesis Phase: Phase 4 Recruitment Status: Recruiting Study Type: Interventional

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: September 11, 2019, Last downloaded: ClinicalTrials.gov processed this data on June 14, 2023, Last updated: June 14, 2023

Study ID:	NCT04085172 SPD503-401 2018-000821-29 TAK-503-401 2022-502630-71
Veröffentlichungen zur Studie:

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PPN (Katalog-ID):	CTG003159019