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Double-blind, Placebo-controlled, Randomised Withdrawal, Extension, Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17

NCT00784654 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2021-06-09

Study results available
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Summary

The main aim of this study is to evaluate the long-term maintenance of efficacy of LDX after administered to children and adolescents aged 6-17 with ADHD for at least 6 months

Conditions

  • ADHD

Interventions

DRUG

Lisdexamfetamine dimesylate (LDX)

LDX 30, 50, or 70mg capsule once per day (open-label and double-blind periods)

DRUG

Placebo

Placebo capsule once per day (double-blind period)

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
2009-01-27
Primary Completion
2011-10-26
Completion
2011-10-26

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • 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 NCT00784654 on ClinicalTrials.gov