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Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate

NCT01106430 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2021-06-11

Study results available
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Summary

This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.

Conditions

  • Attention-Deficit/Hyperactivity Disorder

Interventions

DRUG

Lisdexamfetamine Dimesylate

Oral 30, 50, or 70mg once-daily for 9 weeks

DRUG

Atomoxetine Hydrochloride

Oral 10mg to 100mg once-daily for 9 weeks

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
2010-06-28
Primary Completion
2012-07-19
Completion
2012-07-19

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Hungary
  • Italy
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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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 NCT01106430 on ClinicalTrials.gov