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Completed Phase 3 Interventional Results available

Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study

ClinicalTrials.gov ID: NCT00764868

Public ClinicalTrials.gov record NCT00764868. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 1:59 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Open-Label, Extension, Multi-Center, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Adolescents Aged 13-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT00764868
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shire
Industry
Enrollment
269 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
13 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 12, 2008
Primary completion
Apr 21, 2010
Completion
Apr 21, 2010
Last update posted
Jun 13, 2021

2008 – 2010

United States locations

U.S. sites
45
U.S. states
24
U.S. cities
43
Facility City State ZIP Site status
Clinical Study Centers, LLC Little Rock Arkansas 72205
Valley Clinical Research, Inc. El Centro California 92243
Penninsula Research Associates, Inc. Rolling Hills Estates California 90274
Psychiatric Centers at San Diego (PCSD-Feighner Research Institute) San Diego California 92108
Elite Clinical Trials, Inc. Wildomar California 92595
Florida Clinical Research Center, LLC Bradenton Florida 34208
Sarkis Clinical Trials Gainesville Florida 32607
Amedica Research Institute, Inc. Hialeah Florida 33013
Clinical Neuroscience Solutions, Inc. Jacksonville Florida 32216
Clinical Neuroscience Solutions, Inc. Orlando Florida 32806
Miami Research Associates South Miami Florida 33143
Janus Center for Psychiatric Research West Palm Beach Florida 33407
Atlanta Center for Medical Research Atlanta Georgia 30308
Northwest Behavioral Research Center Marietta Georgia 30060
Capstone Clinical Research Libertyville Illinois 60048
Clinco Inc. Terre Haute Indiana 47802
CIENTIFICA, Inc. at Prairie View Newton Kansas 67114
Psychiatric Associates Overland Park Kansas 66211
Vince and Associates Clinical Research, Inc. Overland Park Kansas 66212
Pedia Research LLC. Owensboro Kentucky 42301
Four Rivers Clinical Research, Inc. Paducah Kentucky 42003
Louisiana Research Associates, Inc. New Orleans Louisiana 70114
Bart Sangal Troy Michigan 48085
Center for Psychiatry and Behavioral Medicine, Inc. Las Vegas Nevada 89128
Children's Specialized Hospital Toms River New Jersey 08755
Bioscience Research, LLC Mount Kisco New York 10549
Triangle Neuropsychiatry, PLLC Durham North Carolina 27707
Innovis Health/Odyssey Research Fargo North Dakota 58104
University Hospitals of Cleveland Division of Child & Adolescent Psychiatry Cleveland Ohio 44106
IPS Research Company Oklahoma City Oklahoma 73103
OCCI Eugene Oregon 97401
Summit Research Network Portland Oregon 97210
OCCI, INC (Oregon Center for Clinical Investigations, Inc.) Salem Oregon 97301
CRI Worldwide Philadelphia Pennsylvania 19139
Youth and Family Research Program/WPIC ADHD Research Program Pittsburgh Pennsylvania 15213
CNS Healthcare Memphis Tennessee 38119
Future Search Trials Austin Texas 78756
Bayou City Research, Ltd. Houston Texas 77007
Red Oak Psychiatry Associates P.A. Houston Texas 77090
ADHD Clinic of San Antonio San Antonio Texas 78247
Vermont Clinical Study Center Burlington Vermont 05401
Neuropsychiatric Associates Woodstock Vermont 05091
Neuroscience, Inc. Herndon Virginia 20170
Dominion Clinical Research Midlothian Virginia 23112
Northwest Clinical Research Center Bellevue Washington 98004

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00764868, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 13, 2021 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00764868 live on ClinicalTrials.gov.

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