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CompletedNCT01328756

Two-Year Safety of Lisdexamfetamine in Children and Teens With ADHD

About this titleRead the official source — NCT01328756

Researchers studied Lisdexamfetamine dimesylate, tracking side effects to assess safety and tolerability in children and adolescents with ADHD.

Medication studyAges 6–17Multiple countries
The study in practice

Understand this study

What did researchers investigate?

Researchers studied Lisdexamfetamine dimesylate, tracking side effects to assess safety and tolerability in children and adolescents with ADHD.

Who was this study for?

This study was for people with ADHD. Listed age limits: 6 years to 17 years. Other eligibility criteria applied.

Listed locations
Hoboken and 34 more locationsSee all locations and recruitment
Study phase
Phase 4Usually happens after approval, to monitor real-world use, safety, and longer-term outcomes.

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Study clarity

Study information

Study start dateStarted: July 7, 2011
Recruitment status
Completed
Enrollment listed in the registry
314
Sponsor
Shire
Sponsor type
Unknown or unclear
Study type
Drug
Intervention type
Drug
Study phase
Phase 4Usually happens after approval, to monitor real-world use, safety, and longer-term outcomes.
Locations
United Kingdom, Belgium, Germany, ...
Age range
From 6 Years to 17 Years
Official registry ID
NCT01328756
Official title
Show the full official title

A Phase 4, Open-Label, Multicentre, Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

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Recruitment & locations

Completed

Hoboken, Belgium · Leuven, Belgium · Freiburg im Breisgau, Germany

32 more locations
  • Mannheim, Germany
  • Bamberg, Germany
  • Würzburg, Germany
  • Hagen, Germany
  • Berlin, Germany
  • Hamburg, Germany
  • Pécs, Hungary
  • Szeged, Hungary
  • Budapest, Hungary
  • Gyula, Hungary
  • Cagliari, Italy
  • Messina, Italy
  • Heerlen, Netherlands
  • Bydgoszcz, Poland
  • Torun, Poland
  • Warsaw, Poland
  • Timișoara, Romania
  • Bucharest, Romania
  • Iași, Romania
  • Palma de Mallorca, Spain
  • Esplugues de Llobregat, Spain
  • Terrassa, Spain
  • Torremolinos, Spain
  • Pamplona, Spain
  • San Cristóbal de La Laguna, Spain
  • Badajoz, Spain
  • Barcelona, Spain
  • Gothenburg, Sweden
  • Mölnlycke, Sweden
  • Stockholm, Sweden
  • Grays, United Kingdom
  • Dundee, United Kingdom

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FAQ

Questions about this study

What did researchers investigate?

Researchers studied Lisdexamfetamine dimesylate, tracking side effects to assess safety and tolerability in children and adolescents with ADHD.

Who is behind this study?

The study sponsor is Shire.

Did this study involve medication?

Yes. The study involved medication, including Lisdexamfetamine dimesylate.

Who was this study for?

This study was for people with ADHD. Listed age limits: 6 years to 17 years. Other eligibility criteria applied.

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