A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic Hyponatremia

PHASE3CompletedINTERVENTIONAL
Enrollment

206

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

November 30, 2010

Conditions
Euvolemic Hyponatremia
Interventions
DRUG

Lixivaptan

Capsules, 25mg lixivaptan or matching placebo once daily. Study medication can be titrated up to 50mg or 100mg once daily. Acceptable dosages are once daily administration of 25mg, 50mg, or 100mg as a single dose.

DRUG

Placebo

Capsule. Subjects will be randomized (3:1) on an outpatient basis to 25 mg lixivaptan or matching placebo, once daily.

Trial Locations (90)

1070

Hospital Erasme, Bruzelles

11040

Parker Jewish Institute for Health Care and Rehabilitation, New Hyde Park

11413

Medical Research Development Associates, LLC, Springfield Gardens

12808

Klinika nefrologie VFN a 1.LF UK, Nemocnice 2

14215

Buffalo VA Medical Center, Buffalo

Erie County Medical Center/SUNY at Buffalo affiliate, Buffalo

14621

Rochester General Hospital, Rochester

15701

Ilumina CLinical Associates, Indiana

18017

Northeast Clinical Research Center, Bethlehem

19428

Translational Neuroscience, LLC/Drexel University College of Medicine, Conshohocken

20127

Instituto Biomedico de Investigacion A.C., Aguascalientes

21215

Levindale Hebrew Geriatric Center and Hospital, Baltimore

LifeBridge Health, Inc./ Courtland Gardens Nursing & Rehabilitation Center, Baltimore

21234

Stephen R. Smith, Baltimore

22030

Clinical Research and Consulting Center, Fairfax

23249

McGuire VA Medical Center, Richmond

27983

Three Rivers Health and Rehabilitation, Windsor

29150

Carolina Diabetes and Kidney Center, Sumter

30094

Rockdale Medicall Research Associates, Conyers

30342

Executive Health and Research Associates, Atlanta

31419

RTR Medical Group, Savannah

32216

Jacksonville Center for CLinical Research, Jacksonville

32833

Universal Clinical Research & Technology, Inc., Orlando

University Clinical Research & Technology, Inc., Orlando

33137

Miami Jewish Home and Hospital for the Aged, Miami

33145

Galiz Research, Miami

33161

Piedmont Clinical Trials, North Miami

Scientific Clinical Research, Inc., North Miami

33166

Galiz Research, Miami Springs

33173

Nephrology Associates of South Miami, Miami

33756

Innovative Research of West Florida, Inc., Clearwater

33952

Coastal Nephrology Associates Reserach Center, Port Charlotte

34070

"Hospital General Dr. Santiago Ramon Y Cajal I.S.S.S.T.E.", Durango

34134

Naples Institute for Clinical Research, Bonita Springs

35205

Birmingham Nursing and Rehabilitation East, Birmingham

36109

Healthscan Research, LLC, Montgomery

38100

Diabetic and Endocrine Unit, Hillel Yaffe Medical Center, Hadera

42003

Four Rivers Clinical Research, Paducah

42100

Medicina II, Arcispedale Santa Maria Nuova, Reggio Emilia

42303

Research Integrity, LLC, Owensboro

44060

Your Diabetes Endocrine Nutrition Group, Inc., Mentor

45224

Hilltop Physicians Inc, Cincinnati

45439

Providence Health Partners - Center for Clinical Research, Dayton

45459

Valley Medical Research, Centerville

49100

The Endocrine Institute, Rabin Medical Center, Beilinson Hospital, Petah Tikvah

52100

Presidio ospedaliero zona aretina, Ospedale San Donato di Arezzo, Pietro Nenni

54013

Kovai Medical Centre & Hospital, Tamil Nadu

58103

Lillestol Research LLC, Fargo

59701

Mercury Street Medical Group, Butte

60126

SOD Clinica di Endocrinologia a Malatte del Metabolismo, Torette Di Ancona

61483

Toulon Health Care Center, Toulon

63044

Millenium Psychiatric Associates, St Louis

63110

SLU Care Doctors Office Building, St Louis

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

68803

Internal Medical Associates of Grand Island, PC, Grand Island

70118

John J. Hainkel Jr Home and Rehabilitation Center, New Orleans

70852

Fakultni nemocnice Ostrava Neurologicke oddeleni, Ostrava

71457

Natchitoches Internal Medicine, Natchitoches

72143

Searcy Medical Center, Searcy

72204

Parkview Rehabilitation and Nursing, Little Rock

73103

COR Clinical Research LLC, Oklahoma City

77024

Memorial Hermann - Memorial City Research Center, Houston

78229

InVisions Consultants, LLC, San Antonio

78501

South Texas Institutes of Health, McAllen

78757

Senior Adults Specialty Research, Austin

80014

Senior Care of Colorado, PC, Aurora

84058

ASpen CLinical Research, Orem

85050

PsyPharma Clinical Research, Inc., Phoenix

PsyPharma Clinical Research, Phoenix

85723

Southern Arizona VA Health Care System (SAVAHCS), Tucson

90250

Sarah S. Olelewe, MD, Inc., Hawthorne

90717

Torrance Clinical Research, Lomita

90746

AV Institute, Inc., Carson

91120

Hadassah Medical Organization, Hadassah University Hospital, Ein Karem, Kiryat Hadassah

91342

Olive View - UCLA Medical Center, Sylmar

92708

Royal Care Nursing Home, Fountain Valley

98405

Universal Research Group, Tacoma

560034

Department of Neurology St. John's Medical College & Hospital, Bangalore

560054

M. S. Ramaiah Memorial Hospital, Bangalore

575018

Justice K. S. Hedge Charitable Hospital, Karnataka

02720

Genesis Clinical Research & Consulting, LLC, Fall River

01107

Western New England Renal & Transplant Assciates, PC, Springfield

380 016

Smt G.R. Doshi & Smt K.M. Mehta Institute of Kidney Diseases & Reseacrh Cnetre (IKDRC) & Dr. H.L. Trivedi Institute of Transplantation Services (ITS), Asarwa

500 068

Kamineni Hospitals, Hyderabad

600 006

Apollo Hospitals, Tanil Nadu

141 001

Dayanand Medical College and Hospital, Tagorenagar

400 007

Bhatia Hospital, G-1 Ward, Mumbia

411 001

Jehangir Clinical Development Centre Pvt. Ltd., Pune

Lima 13

Hospital Nacional Guillermo Almenara Irigoyen-EsSalud., Lima

Lima 1

Hospital Nacional Arzobispo Loayza, Lima

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Cardiokine Biopharma, LLC

INDUSTRY

collaborator

Biogen

INDUSTRY

lead

CardioKine Inc.

INDUSTRY

NCT00876798 - A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic Hyponatremia | Biotech Hunter | Biotech Hunter