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Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17

NCT00763971 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2021-06-14

Study results available
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Summary

The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.

Conditions

  • ADHD

Interventions

DRUG

Lisdexamfetamine Dimesylate (LDX)

30, 50 or 70mg capsule once per day (Overencapsulated)

DRUG

Methylphenidate Hydrochloride

18, 36, or 54mg tablet one per day (Overencapsulated)

DRUG

Placebo

Placebo capsule once per day (Overencapsulated)

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-17
Primary Completion
2011-03-16
Completion
2011-03-16

Countries

  • Belgium
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00763971 on ClinicalTrials.gov