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

This study has been completed.
Sponsor:
Collaborators:
Cardiokine Biopharma, LLC
Biogen Idec
Information provided by:
CardioKine Inc.
ClinicalTrials.gov Identifier:
NCT00578695
First received: December 19, 2007
Last updated: June 20, 2011
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Hyponatremia
Drug: lixivaptan
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation

Resource links provided by NLM:


Further study details as provided by CardioKine Inc.:

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. [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Enrollment: 652
Study Start Date: January 2007
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Lixivaptan
Drug: lixivaptan
Oral Capsule
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Oral Capsule

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients 18 years of age or older with hyponatremia and hospitalized for congestive heart failure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578695

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

No publications provided

Responsible Party: Cardiokine, Ink
ClinicalTrials.gov Identifier: NCT00578695     History of Changes
Other Study ID Numbers: CK-LX3401
Study First Received: December 19, 2007
Last Updated: June 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by CardioKine Inc.:
Hyponatremia
Serum Sodium
Fluid Overload
Heart Failure
Acute Heart Failure
Vasopressin Antagonist

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014