Efficacy and Safety of SPD503 in Combination With Psychostimulants

PHASE3CompletedINTERVENTIONAL
Enrollment

461

Participants

Timeline

Start Date

September 2, 2008

Primary Completion Date

December 10, 2009

Study Completion Date

December 10, 2009

Conditions
ADHD
Interventions
DRUG

SPD503-AM

SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg

DRUG

SPD503-PM

SPD503 (Guanfacine Extended Release)-PM Optimized 1-4mg

DRUG

Placebo

Placebo matched to Guanfacine Hydrochloride Extended Release

Trial Locations (61)

8620

UCSD Department of Psychiatry, San Diego

10312

Richmond Behavioral Associates, Staten Island

10549

Bioscience Research, LLC, Mount Kisco

15065

Western Psychiatric Institute and Clinic, Pittsburgh

20170

NeuroScience, Inc, Herndon

20852

Marc Hertzman, MD, PC, Rockville

21801

Delmarva Family Resources, Salisbury

22903

Psychiatric Alliance of the Blue Ridge Clinical Research, Charlottesville

23112

Dominion Clinical Research, Midlothian

23230

Alliance Research Group, Richmond

Bayou City Research, Richmond

27705

Duke University Medical Center ADHD Program, Durham

27707

Triangle Neuropsychiatry, PLLC, Durham

29812

Peds Research Inc., Barnwell

32216

Clinical Neuroscience Solutions, Inc., Jacksonville

32607

Sarkis Clinical Trials, Gainesville

32751

Florida Clinical Research Center, LLC, Bradenton

Florida Clinical Research Center, LLC, Maitland

32806

Clinical Neuroscience Solutions, Inc., Orlando

33155

Miami Children's Hospital, Miami

33407

Janus Center for Psychiatric Research, West Palm Beach

33912

Gulfcoast Clinical Research Center, Fort Myers

36303

Harmonex Neuroscience Research, Dothan

42301

Pedia Research, LLC, Owensboro

43210

Department of Psychiatry, The Ohio State University, Columbus

44106

University Hospitals Cleveland Medical Center, Cleveland

46260

Goldpoint Clinical Research, LLC, Indianapolis

47630

Pedia Research, Newburgh

48083

Behavioral Medicine Center, Troy

48302

Neurobehaviorial Medicine, Bloomfield Hills

48307

Rochester Center for Behavioral Medicine, Rochester Hills

60523

American Medical Research, Inc, Oak Brook

60563

AMR-Baber Research, Inc., Naperville

63301

Midwest Research Group/St. Charles Psychiatric Associates, Saint Charles

64114

The Center for Pharmaceutical Research, Kansas City

66211

Psychiatric Associates, Overland Park

66212

Vince and Associates Clinical Research, Overland Park

68510

Premier Psychiatric Research Inst. LLC, Lincoln

72205

Clinical Study Centers, LLC, Little Rock

73103

IPS Research, Oklahoma City

75115

InSite Clinical Research, DeSoto

75756

FutureSearch Trials, Austin

77008

Claghorn-Lesem Research Clinic, Inc., Houston

77090

Red Oak Psychiatry Associates, PA, Houston

77488

Wharton Research Center, Wharton

78247

Cerebral Research, LLC, San Antonio

79423

Western Clinical Investigations, Lubbock

85254

Melmed Center, Scottsdale

89128

Centers for Psychiatry and Behavioral Medicine, Las Vegas

90274

Peninsula Research Associates, Rolling Hills Estates

92243

Valley Clinical Research, Inc., El Centro

92595

Elite Clinical Trials, Inc, Wildomar

94143

University of California, San Francisco, San Francisco

97210

Oregon Center for Clinical Investigations, INC (OCCI, Inc.), Portland

Summit Research Network, Portland

97301

Oregon Center for Clinical Investigations, Inc, Salem

97401

Oregon Center for Clinical Investigations, Inc, Eugene

98004

Northwest Clinical Research Center, Bellevue

02138

Massachussests General Hospital, Cambridge

08755

Children's Specialized Hospital, Toms River

05401

Vermont Clinical Study Center, Burlington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT00734578 - Efficacy and Safety of SPD503 in Combination With Psychostimulants | Biotech Hunter | Biotech Hunter