Trial Profile

A Phase 4, Multicenter, 2-part Study Composed of a 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

Status: Active, no longer recruiting

Phase of Trial: Phase IV

Latest Information Update: 06 Aug 2025

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At a glance

Drugs Guanfacine (Primary) ; Atomoxetine
Indications Attention-deficit hyperactivity disorder
Focus Therapeutic Use
Sponsors Shire; Shire Pharmaceutical Development; Takeda Development Center Americas

06 Aug 2025 Last checked against ClinicalTrials.gov record.
22 Jul 2025 Planned End Date changed from 8 Aug 2025 to 2 Sep 2025.
22 Jul 2025 Planned primary completion date changed from 8 Aug 2025 to 2 Sep 2025.

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