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Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study

NCT00764868 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2021-06-14

Study results available
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Summary

The primary objective of this study is to evaluate the long-term safety of LDX administered as a daily morning dose (30, 50, and 70 mg/day) in the treatment of adolescents (13-17 years of age inclusive at the time of consent).

Conditions

  • ADHD

Interventions

DRUG

Lisdexamfetamine Dimesylate (LDX)

optimal dose of 30, 50 or 70 mg once daily

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-11-13
Primary Completion
2010-04-22
Completion
2010-04-22

Countries

  • United States

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 NCT00764868 on ClinicalTrials.gov