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

Primary Purpose

Hyponatremia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
lixivaptan
Placebo
Sponsored by
CardioKine Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyponatremia focused on measuring Hyponatremia, Serum Sodium, Fluid Overload, Heart Failure, Acute Heart Failure, Vasopressin Antagonist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female patients 18 years of age or older with hyponatremia and hospitalized for congestive heart failure.

Sites / Locations

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  • University of Iowa Hospitals and Clinics
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  • Northern Michigan Hospital
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  • Siant Barnabas Medical Center
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  • hospital Interzonal General de Agudos, "Eva Peron" (HIGA)
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  • Hospital Militar Central H Gral. 601 "Cirujano Mayor Dr. Cosme Argerich"
  • Hospital de Clinicas "Jose de San Martin"
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  • Hospital de Puerto Montt
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  • Shree Saibaba Heart Institute and Research Centre
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  • Sir Ganga Ram Hospital
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  • Sri Ramachandra Medical College of research Institute
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  • Azienda Ospedaliero-Universitaria "San Giovanni Battista di Torino" Struttura Complessa Cardiologia 1
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  • Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej
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  • Samodzielnl Szpital Wojewodzki
  • Wojewodzki Szpital Specjalistczny w Radomiu, Oddzial Kardiologil
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej
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  • Wojskowy Instytut Medyczny
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  • Interna klinika, Fakultna nemocnica Trencin
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  • Hospital Univeritario Virgen de la Victoria Servicio de Cardiologia
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Lixivaptan

Placebo

Outcomes

Primary Outcome Measures

To determine whether lixivaptan can effectively and safely produce an increase in serum sodium from Baseline in heart failure subjects with hyponatremia and volume overload. Effects on body weight and other clinical measures will be evaluated.

Secondary Outcome Measures

Full Information

First Posted
December 19, 2007
Last Updated
June 20, 2011
Sponsor
CardioKine Inc.
Collaborators
Cardiokine Biopharma, LLC, Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00578695
Brief Title
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
Official Title
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
CardioKine Inc.
Collaborators
Cardiokine Biopharma, LLC, Biogen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the safety and efficacy of lixivaptan in the treatment of hyponatremia in patients with congestive heart failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyponatremia
Keywords
Hyponatremia, Serum Sodium, Fluid Overload, Heart Failure, Acute Heart Failure, Vasopressin Antagonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
652 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Lixivaptan
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
lixivaptan
Intervention Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Capsule
Primary Outcome Measure Information:
Title
To determine whether lixivaptan can effectively and safely produce an increase in serum sodium from Baseline in heart failure subjects with hyponatremia and volume overload. Effects on body weight and other clinical measures will be evaluated.
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients 18 years of age or older with hyponatremia and hospitalized for congestive heart failure.
Facility Information:
Facility Name
Research Site 1
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Research Site 1
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Research Site 1
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Research Site 1
City
Bakersfield
State/Province
California
ZIP/Postal Code
93308
Country
United States
Facility Name
Research Site 1
City
Banning
State/Province
California
ZIP/Postal Code
92220
Country
United States
Facility Name
Research Site 1
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Research Site
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Research Site 1
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Research Site 1
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Research Site 1
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Research Site 1
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Research Site 1
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Research Site 1
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Research Site 1
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Research Site 1
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Research Site 1
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Facility Name
Research Site 1
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Research Site 1
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Research Site 1
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Research Site 1
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Research Site 1
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
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Research Site 1
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
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Research Site 1
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Research Site 1
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
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Research Site 1
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
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United States
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Research Site 1
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
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Research Site 1
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
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Research Site 1
City
Bannockburn
State/Province
Illinois
ZIP/Postal Code
60015
Country
United States
Facility Name
Research Site 1
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Research Site 1
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Research Site 1
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Research Site 1
City
North Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site 1
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Research Site 1
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61606
Country
United States
Facility Name
Research Site 1
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Research Site 1
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
522442
Country
United States
Facility Name
Research Site 1
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52245
Country
United States
Facility Name
Research Site 1
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Research Site 1
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Research Site 1
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Research Site 1
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Research Site 1
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Research Site 1
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Research Site 1
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Research Site 1
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Northern Michigan Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Research Site 1
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Research Site 1
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Research Site 1
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Research Site 1
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Research Site 1
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Research Site 1
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Research Site 1
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Facility Name
Research Site 1
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Siant Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Research Site 1
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07982
Country
United States
Facility Name
Research Site 1
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Research Site 1
City
Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Facility Name
Research Site 1
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Research Site 1
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Research Site 1
City
Jamaica
State/Province
New York
ZIP/Postal Code
11418
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Research Site 1
City
Northport
State/Province
New York
ZIP/Postal Code
11768
Country
United States
Facility Name
Research Site 1
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Research Site 1
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Research Site 1
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Research Site 1
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Research Site 1
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Research Site 1
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
Facility Name
Research Site
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
Facility Name
Research Site 1
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Research Site 1
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Research Site 1
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Research Site 2
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Research Site 1
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Research Site 1
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Research Site 1
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Research Site 1
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Research Site 1
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Research Site 1
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Research Site1
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Research Site 1
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
Facility Name
Research Site 1
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Research Site 1
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Research Site 1
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Facility Name
Research Site 1
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Research Site 1
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Research Site 1
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Site 1
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Research Site 1
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site 1
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Research Site 1
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Research Site 1
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Research Site 1
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Research Site 1
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Research Site 2
City
Richmond
State/Province
Virginia
ZIP/Postal Code
232225
Country
United States
Facility Name
Research Site 1
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Research Site 1
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Research Site 1
City
Beloit
State/Province
Wisconsin
ZIP/Postal Code
53511
Country
United States
Facility Name
Research Site 1
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
hospital Interzonal General de Agudos, "Eva Peron" (HIGA)
City
San Martin
State/Province
Buenos Aires
ZIP/Postal Code
1650
Country
Argentina
Facility Name
Research Site
City
Ciudad Autonomo de Buenos Aires
State/Province
Galvan
ZIP/Postal Code
CP FWO1431
Country
Argentina
Facility Name
Research Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
CP2000
Country
Argentina
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
1027
Country
Argentina
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
1210
Country
Argentina
Facility Name
Research Site 1
City
Buenos Aires
ZIP/Postal Code
1437
Country
Argentina
Facility Name
Research Site 1
City
Buenos Aires
ZIP/Postal Code
1605
Country
Argentina
Facility Name
Research Site 1
City
Buenos Aires
ZIP/Postal Code
1878
Country
Argentina
Facility Name
Research Site 1
City
Buenos Aires
ZIP/Postal Code
2900
Country
Argentina
Facility Name
Research Site 1
City
Buenos Aires
ZIP/Postal Code
8000
Country
Argentina
Facility Name
Research Site 1
City
Buenos Aires
ZIP/Postal Code
B1708KCH
Country
Argentina
Facility Name
Hospital Militar Central H Gral. 601 "Cirujano Mayor Dr. Cosme Argerich"
City
Buenos Aires
ZIP/Postal Code
C1426BOR
Country
Argentina
Facility Name
Hospital de Clinicas "Jose de San Martin"
City
Buenos Aires
Country
Argentina
Facility Name
Research Site 1
City
Cerrientes
Country
Argentina
Facility Name
Research Site 1
City
Provincia de Buenos Aires
Country
Argentina
Facility Name
Research Site 1
City
Provincia de Misiones
ZIP/Postal Code
3300
Country
Argentina
Facility Name
Research Site 1
City
Provincia de Santa Fe
Country
Argentina
Facility Name
Research Site 1
City
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Research Site 1
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N 2A8
Country
Canada
Facility Name
Research Site 1
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Research Site 1
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1P2T7
Country
Canada
Facility Name
Research Site 1
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Research Site 1
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Research Site 1
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Research Site 1
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Research Site 1
City
St. Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 5T3
Country
Canada
Facility Name
Research Site 1
City
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Research Site 1
City
New Brunswick
ZIP/Postal Code
E2K 4P8
Country
Canada
Facility Name
Research Site 1
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Research Site 1
City
Quebec
ZIP/Postal Code
J6E 6J2
Country
Canada
Facility Name
Research Site 1
City
Vancouver
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Research Site 1
City
Antofagasta
ZIP/Postal Code
1945
Country
Chile
Facility Name
Research Site 1
City
Concepcion
Country
Chile
Facility Name
Research Site 1
City
Orosno
Country
Chile
Facility Name
Hospital de Puerto Montt
City
Puerto Montt
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
0155
Country
Chile
Facility Name
Research Site 1
City
Santiago
ZIP/Postal Code
3204
Country
Chile
Facility Name
Research Site 1
City
Santiago
Country
Chile
Facility Name
Research Site
City
Temuco
ZIP/Postal Code
115
Country
Chile
Facility Name
Research Site 1
City
Vina del Mar
ZIP/Postal Code
1532
Country
Chile
Facility Name
Research Site 1
City
Havlickuv Brod
ZIP/Postal Code
580 22
Country
Czech Republic
Facility Name
Research Site 1
City
Kladno
ZIP/Postal Code
272 59
Country
Czech Republic
Facility Name
Research Site 1
City
Kromeriz
ZIP/Postal Code
767 55
Country
Czech Republic
Facility Name
Research Site 1
City
Liberec
ZIP/Postal Code
460-63
Country
Czech Republic
Facility Name
Research Site 1
City
Mestec Kralove
ZIP/Postal Code
289 03
Country
Czech Republic
Facility Name
Research Site 1
City
Ostrava
ZIP/Postal Code
72880
Country
Czech Republic
Facility Name
Research Site 1
City
Praha 1
Country
Czech Republic
Facility Name
Research Site 1
City
Praha 2
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Research Site 1
City
Praha
ZIP/Postal Code
150 30
Country
Czech Republic
Facility Name
Research Site 1
City
Praha
ZIP/Postal Code
180 81
Country
Czech Republic
Facility Name
Research Site 1
City
Pribram
ZIP/Postal Code
261 26
Country
Czech Republic
Facility Name
Research Site 1
City
Znojmo
ZIP/Postal Code
669 02
Country
Czech Republic
Facility Name
Research Site 1
City
Bad Krozingen
ZIP/Postal Code
71989
Country
Germany
Facility Name
Research Site 1
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Research Site 1
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Facility Name
Research Site 1
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Research Site 1
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Research Site 1
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Research Site 1
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Research Site 1
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Research Site 1
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Research Site 1
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Research Site 1
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Research Site 1
City
Hannover
ZIP/Postal Code
30167
Country
Germany
Facility Name
Research Site 1
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Research Site 1
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Research Site 1
City
Karisbad
ZIP/Postal Code
76307
Country
Germany
Facility Name
Research Site 1
City
Konstanz
ZIP/Postal Code
78464
Country
Germany
Facility Name
Research Site 1
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Research Site 1
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Research Site 1
City
Regensburg
ZIP/Postal Code
94053
Country
Germany
Facility Name
Research Site 1
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Research Site 1
City
Soest
ZIP/Postal Code
59494
Country
Germany
Facility Name
Research Site
City
Secunderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 003
Country
India
Facility Name
Research Site
City
Mogappair
State/Province
Chennai
ZIP/Postal Code
600037
Country
India
Facility Name
Research Site
City
Naranpura
State/Province
Gujarat
ZIP/Postal Code
380014
Country
India
Facility Name
Research Site
City
Panjagutta
State/Province
Hyderabad
ZIP/Postal Code
500082
Country
India
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 034
Country
India
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 054
Country
India
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560052
Country
India
Facility Name
Research Site
City
College Road
State/Province
Nashik
ZIP/Postal Code
422 005
Country
India
Facility Name
Shree Saibaba Heart Institute and Research Centre
City
Shalimar
State/Province
Nashik
ZIP/Postal Code
422 002
Country
India
Facility Name
Research Site
City
Bikaner
ZIP/Postal Code
334001
Country
India
Facility Name
Research Site 1
City
Coimbatore
Country
India
Facility Name
Research Site 1
City
Madhya Pradesh
Country
India
Facility Name
Research Site 1
City
Maharashtra
Country
India
Facility Name
Research Site 1
City
Maharastra
Country
India
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400 007
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110025
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110076
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
Country
India
Facility Name
Research Site 1
City
Rajasthan
Country
India
Facility Name
Sri Ramachandra Medical College of research Institute
City
Tamul Nadu
ZIP/Postal Code
600116
Country
India
Facility Name
Research Site 1
City
Be'er-Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Research Site 1
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Research Site 1
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Research Site 1
City
Jerusalem
ZIP/Postal Code
91004
Country
Israel
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Research Site 1
City
Jerusalem
ZIP/Postal Code
91240
Country
Israel
Facility Name
Research Site 1
City
Petah Tkva
Country
Israel
Facility Name
Research Site 1
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Research Site 1
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Research Site 1
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Research Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Research Site 1
City
Cecina
ZIP/Postal Code
57023
Country
Italy
Facility Name
Research Site 1
City
Cortina
ZIP/Postal Code
52044
Country
Italy
Facility Name
Research Site 1
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Research Site 1
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Research Site 1
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Research Site 1
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Research Site 1
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Research Site 1
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
Facility Name
Research Site 1
City
Ravenna
Country
Italy
Facility Name
Research Site 1
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria "San Giovanni Battista di Torino" Struttura Complessa Cardiologia 1
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Research Site 1
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Research Site
City
Curie 1
State/Province
Nysa
ZIP/Postal Code
48-300
Country
Poland
Facility Name
Research Site 1
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Research Site 1
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Research SIte
City
Kielce
ZIP/Postal Code
25-736
Country
Poland
Facility Name
Research Site 1
City
Krakow
ZIP/Postal Code
31-121
Country
Poland
Facility Name
Research Site 2
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-913
Country
Poland
Facility Name
Research Site
City
Lubartow
ZIP/Postal Code
21-100
Country
Poland
Facility Name
Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej
City
Ostroleka
ZIP/Postal Code
07-410
Country
Poland
Facility Name
Research Site 1
City
Ostrowiec Swietokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Research Site
City
Pabianice
ZIP/Postal Code
95-200
Country
Poland
Facility Name
Samodzielnl Szpital Wojewodzki
City
Piotrkow Trybunalski
ZIP/Postal Code
97-300
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistczny w Radomiu, Oddzial Kardiologil
City
Radom
ZIP/Postal Code
26-617
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
City
Sieradz
ZIP/Postal Code
98-200
Country
Poland
Facility Name
Research Site
City
Starogard Gdanski
Country
Poland
Facility Name
Research Site 1
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Research Site 1
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Research Site 1
City
Warszawa
ZIP/Postal Code
01-211
Country
Poland
Facility Name
Research Site 1
City
Warszawa
ZIP/Postal Code
02-005
Country
Poland
Facility Name
Research Site 1
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Research Site 1
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
Facility Name
Wojskowy Instytut Medyczny
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Research Site 1
City
Warszawa
ZIP/Postal Code
04-749
Country
Poland
Facility Name
Research Site 1
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Research Site 1
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Research Site
City
Brasov
ZIP/Postal Code
500152
Country
Romania
Facility Name
Research Site 1
City
Bucharest
ZIP/Postal Code
014461
Country
Romania
Facility Name
Research Site 1
City
Bucharest
ZIP/Postal Code
030572
Country
Romania
Facility Name
Research Site 1
City
Tg Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Research Site 1
City
Timisoara
ZIP/Postal Code
300310
Country
Romania
Facility Name
Research Site 1
City
Lenskaya
State/Province
Moscow
ZIP/Postal Code
129327
Country
Russian Federation
Facility Name
Research SIte 1
City
Moscow
State/Province
Russia
ZIP/Postal Code
109240
Country
Russian Federation
Facility Name
Research Site 1
City
Moscow
State/Province
Russia
ZIP/Postal Code
111020
Country
Russian Federation
Facility Name
Research SIte 1
City
Moscow
State/Province
Russia
ZIP/Postal Code
115487
Country
Russian Federation
Facility Name
Research Site 1
City
Moscow
State/Province
Russia
ZIP/Postal Code
115516
Country
Russian Federation
Facility Name
Research Site 1
City
Moscow
State/Province
Russia
ZIP/Postal Code
119192
Country
Russian Federation
Facility Name
Research Site 1
City
Moscow
State/Province
Russia
ZIP/Postal Code
119620
Country
Russian Federation
Facility Name
Research Site 1
City
Moscow
State/Province
Russia
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
Research Site 1
City
Moscow
State/Province
Russia
ZIP/Postal Code
123423
Country
Russian Federation
Facility Name
Research Site 1
City
Moscow
State/Province
Russia
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Research Site 1
City
Moscow
State/Province
Russia
ZIP/Postal Code
127018
Country
Russian Federation
Facility Name
Research Site 1
City
Moscow
State/Province
Russia
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
Research Site
City
Moscow
State/Province
Russia
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Research Site 1
City
Moscow
State/Province
Russia
ZIP/Postal Code
129301
Country
Russian Federation
Facility Name
Research Site 1
City
Moscow
State/Province
Russia
ZIP/Postal Code
129336
Country
Russian Federation
Facility Name
Research Site 1
City
Moscow
State/Province
Russia
Country
Russian Federation
Facility Name
Research Site 1
City
Saint-Petersburg
State/Province
Russia
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
Research Site 1
City
Saint-Petersburg
State/Province
Russia
ZIP/Postal Code
194156
Country
Russian Federation
Facility Name
Research Site 1
City
Saint-Petersburg
State/Province
Russia
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Research Site 1
City
Saint-Petersburg
State/Province
Russia
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Research Site 1
City
Saint-Petersburg
State/Province
Russia
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Research Site 1
City
L'va Tolstogo
State/Province
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site 1
City
Solidamosty
State/Province
Saint-Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Research Site 1
City
Saint Petersburg
ZIP/Postal Code
191187
Country
Russian Federation
Facility Name
Research Site 1
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Research Site 1
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Interna klinika, Fakultna nemocnica Trencin
City
Trencin
ZIP/Postal Code
91171
Country
Slovakia
Facility Name
Research Site 1
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Research Site 1
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site 1
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Research Site 1
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Univeritario Virgen de la Victoria Servicio de Cardiologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Research Site 1
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Research Site 1
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Research Site 1
City
Vigo
ZIP/Postal Code
36200
Country
Spain
Facility Name
Research Site
City
Geneva
ZIP/Postal Code
1217
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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