Completed

A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Forced-dose Titration, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Adolescents Aged 13-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

LDX 30 mg

+ LDX 50 mg

+ LDX 70 mg

Drug
Who is being recruted

Attention Deficit Disorder with Hyperactivity+1

+ Mental Disorders

+ Attention Deficit and Disruptive Behavior Disorders

From 13 to 17 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: October 2008
See protocol details

Summary

Principal SponsorShire
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 8, 2008

Actual date on which the first participant was enrolled.

The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.

Official TitleA Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Forced-dose Titration, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Adolescents Aged 13-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT00735371
Principal SponsorShire
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

314 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 13 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Attention Deficit Disorder with HyperactivityMental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Criteria

3 inclusion criteria required to participate
Meet DSM-IV-TR criteria for a primary diagnosis of ADHD
Baseline ADHD-RS-IV score >=28
BP w/in 95th percentile for age, gender, and height
5 exclusion criteria prevent from participating
Subject has controlled or uncontrolled comorbid psychiatric diagnosis
Subject has conduct disorder
Suicidal
Under or overweight
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Group II

Active Comparator

Group III

Active Comparator

Group IV

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 45 locations

Suspended

Clinical Study Centers, LLC

Little Rock, United StatesOpen Clinical Study Centers, LLC in Google Maps
Suspended

Valley Clinical Research, Inc.

El Centro, United States
Suspended

Peninsula Research Associates, Inc

Rolling Hills Estates, United States
Suspended

Psychiatric Centers at San Diego (PCSD-Feighner Research Institute)

San Diego, United States
Completed45 Study Centers