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Sponsored by: |
Shire Pharmaceutical Development |
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Information provided by: | Shire Pharmaceutical Development |
ClinicalTrials.gov Identifier: | NCT00784654 |
The main aim of this study is to evaluate the safety of LDX when administered to children and adolescents aged 6-17 with ADHD for 52 weeks
Condition | Intervention | Phase |
---|---|---|
ADHD |
Drug: LDX |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase III, Open-Label, Extension, Multicentre, Safety Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD) |
Estimated Enrollment: | 238 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
LDX: Experimental
Open-label LDX 30, 50, or 70mg
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Drug: LDX
LDX 30, 50, or 70mg capsule once per day
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Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Shire Pharmaceuticals ( Timothy Whitaker, MD ) |
Study ID Numbers: | SPD489-326 |
Study First Received: | November 3, 2008 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00784654 |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency |
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