Trial Profile
A Phase 3, Randomised, Double-blind, Multicentre, Parallel-group, Placebo- and Active-reference, Dose-optimisation Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 07 Nov 2023
Price :
$35
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At a glance
- Drugs Guanfacine (Primary) ; Atomoxetine
- Indications Attention-deficit hyperactivity disorder
- Focus Registrational; Therapeutic Use
- Sponsors Shire
- 29 Jul 2018 Results of post hoc analysis of four studies (SPD503-301, SPD503-304, SPD503-312 and SPD503-316) published in the European Neuropsychopharmacology
- 20 Sep 2016 Results of pooled post hoc analysis of this and other trial (NCT01081132) presented at the 29th Annual Congress of the European College of Neuropsychopharmacology
- 21 Sep 2015 According to a Shire media release, the European Commission has granted Marketing Authorisation for once-daily, non-stimulant INTUNIV for the treatment of attention deficit hyperactivity disorder in children and adolescents 6 to 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective