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Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder

NCT01552915 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 464

Last updated 2021-06-08

Study results available
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Summary

The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).

Conditions

  • Attention-deficit/Hyperactivity Disorder

Interventions

DRUG

Lisdexamfetamine dimesylate

Daily oral dosing in the AM of optimized dose, ranging from 30- 70 mg. 5 week dose optimization, 3 week dose maintenance

DRUG

Methylphenidate Hydrochloride

Daily oral dosing in the AM of optimized dose, ranging from 18-72 mg. 5 week dose optimization, 3 week dose maintenance

DRUG

Placebo

Daily oral dosing in the AM for 8 weeks

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-04-17
Primary Completion
2014-01-22
Completion
2014-01-22

Countries

  • United States

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 NCT01552915 on ClinicalTrials.gov