WHO ICTRP trial

A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and…

EUCTR2008-000679-90-GB · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2008-000679-90-GB
Public title A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents aged 6-17 with Attention-Deficit/Hyperactivity Disorder (ADHD)
Scientific title A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents aged 6-17 with Attention-Deficit/Hyperactivity Disorder (ADHD)
Primary sponsor Shire Pharmaceutical Development Limited
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Countries Hungary;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden
Conditions Attention Deficit / Hyperactivity Disorder (ADHD) MedDRA version: 9.1 Level: LLT Classification code 10064104 Term: ADHD
Interventions Product Name: Lisdexamfetamine dimesylate (LDX) Product Code: SPD489 Pharmaceutical Form: Capsule* CAS Number: 608137-33-3 Current Sponsor code: SPD489 Other descriptive name: Lisdexamfetamine dimesylate (LDX) Concentration unit: mg…
Registration date May 16, 2008
Target size 333
Secondary IDs SPD489-325
Registry page clinicaltrialsregister.eu

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