Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

PHASE3CompletedINTERVENTIONAL
Enrollment

314

Participants

Timeline

Start Date

October 8, 2008

Primary Completion Date

April 6, 2009

Study Completion Date

April 6, 2009

Conditions
Attention Deficit Hyperactivity Disorder (ADHD)
Interventions
DRUG

LDX 30 mg

Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.

DRUG

LDX 50 mg

Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.

DRUG

LDX 70 mg

Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.

DRUG

Placebo

Placebo will be identical to test product.

Trial Locations (45)

10549

Bioscience Research, LLC, Mount Kisco

15213

Youth and Family Research Program/WP IC ADHD Research Program, Pittsburgh

19139

CRI Worldwide, Philadelphia

20170

Neuroscience, Inc, Herndon

23112

Dominion Clinical Research, Midlothian

27707

Triangle Neuropsychiatry, PLLC, Durham

30060

Northwest Behavioral Research Center, Marietta

30308

Atlanta Center for Medical Research, Atlanta

32216

Clinical Neuroscience Solutions, Inc., Jacksonville

32607

Sarkis Clinical Trials, Gainesville

33013

Amedica Research Institute, Inc., Hialeah

33143

Miami Research Associates, South Miami

33407

Janus Center for Psychiatric Research, West Palm Beach

34208

Florida Clinical Research Center, LLC, Bradenton

38119

Valerie Arnold, Memphis

42003

Four Rivers Clinical Research, Inc., Paducah

42301

Pedia Research, LLC, Owensboro

44106

University Hospitals of Cleveland Division of Child Adolescent Psychiatry, Cleveland

47802

Clinco Inc., Terre Haute

48085

Bart Sangal, MD, Troy

58104

Innovis Health/Odyssey Research, Fargo

60048

Capstone Clinical Research, Libertyville

66211

Psychiatric Associates, Overland Park

66212

Vince and Associates Clinical Research, Inc., Overland Park

67114

Cientifica, Inc at Prairie View, Newton

70114

Louisiana Research Associates, Inc, New Orleans

72205

Clinical Study Centers, LLC, Little Rock

73103

IPS Research Company, Oklahoma City

77007

Bayou City Research, Ltd, Houston

77090

Red Oak Psychiatry Associates, PA, Houston

78247

ADHD Clinic of San Antonio, San Antonio

78756

FutureSearch Trials, Austin

89128

Center for Psychiatry and Behavioral Medicine, Inc, Las Vegas

90274

Peninsula Research Associates, Inc, Rolling Hills Estates

92108

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

92243

Valley Clinical Research, Inc., El Centro

92595

Elite Clinical Trials, Inc, Wildomar

97210

Summit Research Network, Portland

97301

OCCI Inc, Salem

97401

OCCI, Eugene

98004

Northwest Clinical Research Center, Bellevue

32806-1122

Clinical Neuroscience Solutions, Inc., Orlando

08755

Children's Specialized Hospital, Toms River

05401

Vermont Clinical Study Center, Burlington

05091

Neuropsychiatric Associates, Woodstock

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT00735371 - Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) | Biotech Hunter | Biotech Hunter