THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation

PHASE3CompletedINTERVENTIONAL
Enrollment

652

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

June 30, 2010

Conditions
Hyponatremia
Interventions
DRUG

lixivaptan

Oral Capsule

DRUG

Placebo

Oral Capsule

Trial Locations (287)

115

Research Site, Temuco

1027

Research Site, Buenos Aires

1210

Research Site, Buenos Aires

1217

Research Site, Geneva

1437

Research Site 1, Buenos Aires

1532

Research Site 1, Viña del Mar

1605

Research Site 1, Buenos Aires

1650

"hospital Interzonal General de Agudos, Eva Peron (HIGA)", San Martín

1878

Research Site 1, Buenos Aires

1945

Research Site 1, Antofagasta

2900

Research Site 1, Buenos Aires

3204

Research Site 1, Santiago

3300

Research Site 1, Provincia de Misiones

4000

Research Site 1, San Miguel de Tucumán

8000

Research Site 1, Buenos Aires

10029

Research Site, New York

10126

Research Site 1, Torino

"Azienda Ospedaliero-Universitaria San Giovanni Battista di Torino Struttura Complessa Cardiologia 1", Torino

10461

Research Site 1, The Bronx

10595

Research Site 1, Valhalla

11418

Research Site 1, Jamaica

11768

Research Site 1, Northport

11794

Research Site 1, Stony Brook

12200

Research Site 1, Berlin

13100

Research Site 1, Safed

13353

Research Site 1, Berlin

14004

Research Site 1, Córdoba

15009

Research Site 1, Beaver

15212

Research Site 1, Pittsburgh

15706

Research Site 1, Santiago de Compostela

16132

Research Site 1, Genova

17011

Research Site 1, Camp Hill

17475

Research Site 1, Greifswald

17822

Research Site 1, Danville

18057

Research Site 1, Rostock

18840

Research Site1, Sayre

18960

Research Site 1, Sellersville

19718

Research Site 1, Newark

20010

Research Site 1, Washington D.C.

20132

Research Site 1, Milan

20246

Research Site 1, Hamburg

21229

Research Site 1, Baltimore

23249

Research Site 1, Richmond

23320

Research Site 1, Chesapeake

23795

Research Site 1, Bad Segeberg

25123

Research Site, Brescia

27100

Research Site 1, Pavia

Research Site 1, Pavia

27157

Research Site 1, Winston-Salem

28007

Research Site 1, Madrid

28100

Research Site 1, Novara

29010

Hospital Univeritario Virgen de la Victoria Servicio de Cardiologia, Málaga

Research Site 1, Málaga

29100

Research Site 1, Piacenza

30167

Research Site 1, Hanover

30322

Research Site 1, Atlanta

30625

Research Site 1, Hanover

31048

Research Site, Haifa

Research Site 1, Haifa

32209

Research Site 1, Jacksonville

32216

Research Site 1, Jacksonville

32224

Research Site 1, Jacksonville

32610

Research Site 1, Gainesville

33136

Research Site 1, Miami

33316

Research Site 1, Fort Lauderdale

33606

Research Site 1, Tampa

33613

Research Site 1, Tampa

33744

Research Site 1, Bay Pines

33805

Research Site 1, Lakeland

33952

Research Site 1, Port Charlotte

35211

Research Site 1, Birmingham

35294

Research Site 1, Birmingham

36200

Research Site 1, Vigo

36604

Research Site 1, Mobile

37075

Research Site 1, Göttingen

37208

Research Site 1, Nashville

37403

Research Site 1, Chattanooga

38138

Research Site 1, Germantown

40138

Research Site 1, Bologna

40202

Research Site 1, Louisville

40207

Research Site 1, Louisville

43100

Research Site 1, Parma

43205

Research Site 1, Columbus

43614

Research Site 1, Toledo

45014

Research Site 1, Fairfield

Research Site, Fairfield

45042

Research Site 1, Middletown

45267

Research Site 1, Cincinnati

46321

Research Site 1, Munster

48201

Research Site, Detroit

48202

Research Site 1, Detroit

49684

Research Site 1, Traverse City

49770

Northern Michigan Hospital, Petoskey

Research Site 1, Petoskey

52044

Research Site 1, Cortina

52245

Research Site 1, Iowa City

53105

Research Site 1, Bonn

53511

Research Site 1, Beloit

53792

Research Site 1, Madison

55805

Research Site 1, Duluth

57023

Research Site 1, Cecina

58100

Research Site 1, Holon

59494

Research Site 1, Soest

60015

Research Site 1, Bannockburn

60153

Research Site 1, Maywood

60453

Research Site 1, Oak Lawn

60612

Research Site 1, Chicago

61231

Research Site 1, Bad Nauheim

61606

Research Site 1, Peoria

61614

Research Site 1, Peoria

61761

Research Site 1, Normal

63104

Research Site 1, St Louis

63110

Research Site 1, St Louis

64239

Research Site 1, Tel Aviv

68506

Research Site 1, Lincoln

70112

Research Site 1, New Orleans

70458

Research Site 1, Slidell

71989

Research Site 1, Bad Krozingen

72880

Research Site 1, Ostrava

73112

Research Site 1, Oklahoma City

73120

Research Site 2, Oklahoma City

74133

Research Site 1, Tulsa

75230

Research Site 1, Dallas

75231

Research Site 1, Dallas

75701

Research Site 1, Tyler

76307

Research Site 1, Karisbad

76508

Research Site 1, Temple

77030

Research Site 1, Houston

77074

Research Site 1, Houston

77555

Research Site 1, Galveston

78464

Research Site 1, Konstanz

79106

Research Site 1, Amarillo

79410

Research Site 1, Lubbock

80045

Research Site 1, Aurora

84101

Research Site 1, Beersheba

90048

Research Site 1, Los Angeles

91004

Research Site 1, Jerusalem

91120

Research Site, Jerusalem

91171

Interna klinika, Fakultna nemocnica Trencin, Trenčín

91204

Research Site 1, Glendale

Research Site, Glendale

91240

Research Site 1, Jerusalem

92103

Research Site 1, San Diego

92161

Research Site 1, San Diego

92220

Research Site 1, Banning

92691

Research Site 1, Mission Viejo

93053

Research Site 1, Regensburg

93308

Research Site 1, Bakersfield

94053

Research Site 1, Regensburg

95661

Research Site 1, Roseville

96450

Research Site 1, Coburg

97477

Research Site 1, Springfield

98195

Research Site 1, Seattle

109240

Research SIte 1, Moscow

110025

Research Site, New Delhi

110076

Research Site, New Delhi

111020

Research Site 1, Moscow

115487

Research SIte 1, Moscow

115516

Research Site 1, Moscow

119192

Research Site 1, Moscow

119620

Research Site 1, Moscow

121359

Research Site 1, Moscow

123423

Research Site 1, Moscow

125284

Research Site 1, Moscow

127018

Research Site 1, Moscow

127473

Research Site 1, Moscow

129110

Research Site, Moscow

129301

Research Site 1, Moscow

129327

Research Site 1, Lenskaya

129336

Research Site 1, Moscow

191187

Research Site 1, Saint Petersburg

192242

Research Site 1, Saint Petersburg

193312

Research Site 1, Solidamosty

194156

Research Site 1, Saint Petersburg

196247

Research Site 1, Saint Petersburg

197022

Research Site 1, L'va Tolstogo

197110

Research Site 1, Saint Petersburg

199106

Research Site 1, Saint Petersburg

232225

Research Site 2, Richmond

300310

Research Site 1, Timișoara

334001

Research Site, Bikaner

380014

Research Site, Naranpura

500082

Research Site, Panjagutta

500152

Research Site, Brasov

522442

University of Iowa Hospitals and Clinics, Iowa City

540136

Research Site 1, Tg Mures

560052

Research Site, Bangalore

600037

Research Site, Mogappair

600116

Sri Ramachandra Medical College of research Institute, Tamul Nadu

Unknown

Research Site 1, North Chicago

Research Site 1, Cerrientes

Research Site 1, Provincia de Buenos Aires

Research Site 1, Provincia de Santa Fe

"Hospital de Clinicas Jose de San Martin", Buenos Aires

Research Site 1, Concepción

Research Site 1, Orosno

Research Site 1, Santiago

Hospital de Puerto Montt, Port Montt

Research Site 1, Prague

Research Site 1, Coimbatore

Research Site 1, Madhya Pradesh

Research Site 1, Maharashtra

Research Site 1, Maharastra

Research Site 1, Rajasthan

Sir Ganga Ram Hospital, New Delhi

Research Site 1, Petah Tkva

Research Site 1, Ravenna

Research Site, Starogard Gdański

Research Site 1, Moscow

02118

Research Site 1, Boston

01805

Research Site 1, Burlington

03301

Research Site 1, Concord

07601

Research Site 1, Hackensack

07039

Siant Barnabas Medical Center, Livingston

07982

Research Site 1, Morristown

07112

Research Site 1, Newark

07052

Research Site 1, Orange

07652

Research Site 1, Paramus

B1708KCH

Research Site 1, Buenos Aires

CP FWO1431

Research Site, Ciudad Autonomo de Buenos Aires

CP2000

Research Site, Rosario

C1426BOR

"Hospital Militar Central H Gral. 601 Cirujano Mayor Dr. Cosme Argerich", Buenos Aires

N2N 2A8

Research Site 1, Kitchener

K1Y 4W7

Research Site 1, Ottawa

M1P2T7

Research Site 1, Scarborough Village

M5G 2N2

Research Site 1, Toronto

H2W 1T8

Research Site 1, Montreal

H3A 1A1

Research Site 1, Montreal

J7Z 5T3

Research Site 1, Saint-Jérôme

J1H 5N4

Research Site 1, Sherbrooke

R2H 2A6

Research Site 1, Manitoba

E2K 4P8

Research Site 1, New Brunswick

G1V 4G5

Research Site 1, Québec

J6E 6J2

Research Site 1, Québec

V6Z 1Y6

Research Site 1, Vancouver

0155

Research Site, Santiago

580 22

Research Site 1, Havlíčkův Brod

272 59

Research Site 1, Kladno

767 55

Research Site 1, Kroměříž

460-63

Research Site 1, Liberec

289 03

Research Site 1, Městec Králové

128 08

Research Site 1, Prague

150 30

Research Site 1, Prague

180 81

Research Site 1, Prague

261 26

Research Site 1, Příbram

669 02

Research Site 1, Znojmo

01307

Research Site 1, Dresden

07747

Research Site 1, Jena

04289

Research Site 1, Leipzig

500 003

Research Site, Secunderabad

560 034

Research Site, Bangalore

560 054

Research Site, Bangalore

422 005

Research Site, College Road

422 002

Shree Saibaba Heart Institute and Research Centre, Shalimar

400 007

Research Site, Mumbai

00161

Research Site 1, Roma

48-300

Research Site, Curie 1

85-168

Research Site 1, Bydgoszcz

Research Site 1, Bydgoszcz

81-519

Research Site 1, Gdynia

25-736

Research SIte, Kielce

31-121

Research Site 1, Krakow

31-501

Research Site 2, Krakow

31-913

Research Site, Krakow

21-100

Research Site, Lubartów

27-400

Research Site 1, Ostrowiec Świętokrzyski

07-410

Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej, Ostrołęka

95-200

Research Site, Pabianice

97-300

Samodzielnl Szpital Wojewodzki, Piotrkow Trybunalski

26-617

Wojewodzki Szpital Specjalistczny w Radomiu, Oddzial Kardiologil, Radom

98-200

Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Sieradz

87-100

Research Site 1, Torun

00-909

Research Site 1, Warsaw

01-211

Research Site 1, Warsaw

02-005

Research Site 1, Warsaw

02-507

Research Site 1, Warsaw

02-637

Research Site 1, Warsaw

04-141

Wojskowy Instytut Medyczny, Warsaw

04-749

Research Site 1, Warsaw

50-367

Research Site 1, Wroclaw

51-124

Research Site 1, Wroclaw

030572

Research Site 1, Bucharest

014461

Research Site 1, Bucharest

826 06

Research Site 1, Bratislava

949 01

Research Site 1, Nitra

08003

Research Site 1, Barcelona

08036

Research Site 1, Barcelona

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Cardiokine Biopharma, LLC

INDUSTRY

collaborator

Biogen

INDUSTRY

lead

CardioKine Inc.

INDUSTRY