THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
1 other identifier
interventional
652
15 countries
287
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
287 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 19, 2007
CompletedFirst Posted
Study publicly available on registry
December 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedJune 28, 2011
November 1, 2010
3.4 years
December 19, 2007
June 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
60 days
Study Arms (2)
Active
EXPERIMENTALLixivaptan
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Male and female patients 18 years of age or older with hyponatremia and hospitalized for congestive heart failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CardioKine Inc.lead
- Cardiokine Biopharma, LLCcollaborator
- Biogencollaborator
Study Sites (287)
Research Site 1
Birmingham, Alabama, 35211, United States
Research Site 1
Birmingham, Alabama, 35294, United States
Research Site 1
Mobile, Alabama, 36604, United States
Research Site 1
Bakersfield, California, 93308, United States
Research Site 1
Banning, California, 92220, United States
Research Site 1
Glendale, California, 91204, United States
Research Site
Glendale, California, 91204, United States
Research Site 1
Los Angeles, California, 90048, United States
Research Site 1
Mission Viejo, California, 92691, United States
Research Site 1
Roseville, California, 95661, United States
Research Site 1
San Diego, California, 92103, United States
Research Site 1
San Diego, California, 92161, United States
Research Site 1
Aurora, Colorado, 80045, United States
Research Site 1
Newark, Delaware, 19718, United States
Research Site 1
Washington D.C., District of Columbia, 20010, United States
Research Site 1
Bay Pines, Florida, 33744, United States
Research Site 1
Fort Lauderdale, Florida, 33316, United States
Research Site 1
Gainesville, Florida, 32610, United States
Research Site 1
Jacksonville, Florida, 32209, United States
Research Site 1
Jacksonville, Florida, 32216, United States
Research Site 1
Jacksonville, Florida, 32224, United States
Research Site 1
Lakeland, Florida, 33805, United States
Research Site 1
Miami, Florida, 33136, United States
Research Site 1
Port Charlotte, Florida, 33952, United States
Research Site 1
Tampa, Florida, 33606, United States
Research Site 1
Tampa, Florida, 33613, United States
Research Site 1
Atlanta, Georgia, 30322, United States
Research Site 1
Bannockburn, Illinois, 60015, United States
Research Site 1
Chicago, Illinois, 60612, United States
Research Site 1
Maywood, Illinois, 60153, United States
Research Site 1
Normal, Illinois, 61761, United States
Research Site 1
North Chicago, Illinois, United States
Research Site 1
Oak Lawn, Illinois, 60453, United States
Research Site 1
Peoria, Illinois, 61606, United States
Research Site 1
Peoria, Illinois, 61614, United States
Research Site 1
Munster, Indiana, 46321, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 522442, United States
Research Site 1
Iowa City, Iowa, 52245, United States
Research Site 1
Louisville, Kentucky, 40202, United States
Research Site 1
Louisville, Kentucky, 40207, United States
Research Site 1
New Orleans, Louisiana, 70112, United States
Research Site 1
Slidell, Louisiana, 70458, United States
Research Site 1
Baltimore, Maryland, 21229, United States
Research Site 1
Boston, Massachusetts, 02118, United States
Research Site 1
Burlington, Massachusetts, 01805, United States
Research Site
Detroit, Michigan, 48201, United States
Research Site 1
Detroit, Michigan, 48202, United States
Northern Michigan Hospital
Petoskey, Michigan, 49770, United States
Research Site 1
Petoskey, Michigan, 49770, United States
Research Site 1
Traverse City, Michigan, 49684, United States
Research Site 1
Duluth, Minnesota, 55805, United States
Research Site 1
St Louis, Missouri, 63104, United States
Research Site 1
St Louis, Missouri, 63110, United States
Research Site 1
Lincoln, Nebraska, 68506, United States
Research Site 1
Concord, New Hampshire, 03301, United States
Research Site 1
Hackensack, New Jersey, 07601, United States
Siant Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Research Site 1
Morristown, New Jersey, 07982, United States
Research Site 1
Newark, New Jersey, 07112, United States
Research Site 1
Orange, New Jersey, 07052, United States
Research Site 1
Paramus, New Jersey, 07652, United States
Research Site 1
Jamaica, New York, 11418, United States
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New York, New York, 10029, United States
Research Site 1
Northport, New York, 11768, United States
Research Site 1
Stony Brook, New York, 11794, United States
Research Site 1
The Bronx, New York, 10461, United States
Research Site 1
Valhalla, New York, 10595, United States
Research Site 1
Winston-Salem, North Carolina, 27157, United States
Research Site 1
Cincinnati, Ohio, 45267, United States
Research Site 1
Columbus, Ohio, 43205, United States
Research Site 1
Fairfield, Ohio, 45014, United States
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Fairfield, Ohio, 45014, United States
Research Site 1
Middletown, Ohio, 45042, United States
Research Site 1
Toledo, Ohio, 43614, United States
Research Site 1
Oklahoma City, Oklahoma, 73112, United States
Research Site 2
Oklahoma City, Oklahoma, 73120, United States
Research Site 1
Tulsa, Oklahoma, 74133, United States
Research Site 1
Springfield, Oregon, 97477, United States
Research Site 1
Beaver, Pennsylvania, 15009, United States
Research Site 1
Camp Hill, Pennsylvania, 17011, United States
Research Site 1
Danville, Pennsylvania, 17822, United States
Research Site 1
Pittsburgh, Pennsylvania, 15212, United States
Research Site1
Sayre, Pennsylvania, 18840, United States
Research Site 1
Sellersville, Pennsylvania, 18960, United States
Research Site 1
Chattanooga, Tennessee, 37403, United States
Research Site 1
Germantown, Tennessee, 38138, United States
Research Site 1
Nashville, Tennessee, 37208, United States
Research Site 1
Amarillo, Texas, 79106, United States
Research Site 1
Dallas, Texas, 75230, United States
Research Site 1
Dallas, Texas, 75231, United States
Research Site 1
Galveston, Texas, 77555, United States
Research Site 1
Houston, Texas, 77030, United States
Research Site 1
Houston, Texas, 77074, United States
Research Site 1
Lubbock, Texas, 79410, United States
Research Site 1
Temple, Texas, 76508, United States
Research Site 1
Tyler, Texas, 75701, United States
Research Site 1
Chesapeake, Virginia, 23320, United States
Research Site 2
Richmond, Virginia, 232225, United States
Research Site 1
Richmond, Virginia, 23249, United States
Research Site 1
Seattle, Washington, 98195, United States
Research Site 1
Beloit, Wisconsin, 53511, United States
Research Site 1
Madison, Wisconsin, 53792, United States
Research Site
Buenos Aires, Argentina, 1210, Argentina
Research Site 1
Buenos Aires, Argentina, 1437, Argentina
Research Site 1
Buenos Aires, Argentina, 1605, Argentina
Research Site 1
Buenos Aires, Argentina, 1878, Argentina
Research Site 1
Buenos Aires, Argentina, 2900, Argentina
Research Site 1
Buenos Aires, Argentina, 8000, Argentina
Research Site 1
Buenos Aires, Argentina, B1708KCH, Argentina
Research Site 1
Cerrientes, Argentina, Argentina
Research Site 1
Provincia de Buenos Aires, Argentina, Argentina
Research Site 1
Provincia de Misiones, Argentina, 3300, Argentina
Research Site 1
Provincia de Santa Fe, Argentina, Argentina
Research Site 1
San Miguel de Tucumán, Argentina, 4000, Argentina
hospital Interzonal General de Agudos, "Eva Peron" (HIGA)
San Martín, Buenos Aires, 1650, Argentina
Research Site
Ciudad Autonomo de Buenos Aires, Galvan, CP FWO1431, Argentina
Research Site
Rosario, Santa Fe Province, CP2000, Argentina
Research Site
Buenos Aires, 1027, Argentina
Hospital Militar Central H Gral. 601 "Cirujano Mayor Dr. Cosme Argerich"
Buenos Aires, C1426BOR, Argentina
Hospital de Clinicas "Jose de San Martin"
Buenos Aires, Argentina
Research Site 1
Kitchener, Ontario, N2N 2A8, Canada
Research Site 1
Ottawa, Ontario, K1Y 4W7, Canada
Research Site 1
Scarborough Village, Ontario, M1P2T7, Canada
Research Site 1
Toronto, Ontario, M5G 2N2, Canada
Research Site 1
Montreal, Quebec, H2W 1T8, Canada
Research Site 1
Montreal, Quebec, H3A 1A1, Canada
Research Site 1
Saint-Jérôme, Quebec, J7Z 5T3, Canada
Research Site 1
Sherbrooke, Quebec, J1H 5N4, Canada
Research Site 1
Manitoba, R2H 2A6, Canada
Research Site 1
New Brunswick, E2K 4P8, Canada
Research Site 1
Québec, G1V 4G5, Canada
Research Site 1
Québec, J6E 6J2, Canada
Research Site 1
Vancouver, V6Z 1Y6, Canada
Research Site 1
Antofagasta, Chile, 1945, Chile
Research Site 1
Concepción, Chile, Chile
Research Site 1
Orosno, Chile, Chile
Research Site 1
Santiago, Chile, 3204, Chile
Research Site 1
Santiago, Chile, Chile
Research Site
Temuco, Chile, 115, Chile
Research Site 1
Viña del Mar, Chile, 1532, Chile
Hospital de Puerto Montt
Port Montt, Chile
Research Site
Santiago, 0155, Chile
Research Site 1
Havlíčkův Brod, 580 22, Czechia
Research Site 1
Kladno, 272 59, Czechia
Research Site 1
Kroměříž, 767 55, Czechia
Research Site 1
Liberec, 460-63, Czechia
Research Site 1
Městec Králové, 289 03, Czechia
Research Site 1
Ostrava, 72880, Czechia
Research Site 1
Prague, 128 08, Czechia
Research Site 1
Prague, 150 30, Czechia
Research Site 1
Prague, 180 81, Czechia
Research Site 1
Prague, Czechia
Research Site 1
Příbram, 261 26, Czechia
Research Site 1
Znojmo, 669 02, Czechia
Research Site 1
Bad Krozingen, 71989, Germany
Research Site 1
Bad Nauheim, 61231, Germany
Research Site 1
Bad Segeberg, 23795, Germany
Research Site 1
Berlin, 12200, Germany
Research Site 1
Berlin, 13353, Germany
Research Site 1
Bonn, 53105, Germany
Research Site 1
Coburg, 96450, Germany
Research Site 1
Dresden, 01307, Germany
Research Site 1
Göttingen, 37075, Germany
Research Site 1
Greifswald, 17475, Germany
Research Site 1
Hamburg, 20246, Germany
Research Site 1
Hanover, 30167, Germany
Research Site 1
Hanover, 30625, Germany
Research Site 1
Jena, 07747, Germany
Research Site 1
Karisbad, 76307, Germany
Research Site 1
Konstanz, 78464, Germany
Research Site 1
Leipzig, 04289, Germany
Research Site 1
Regensburg, 93053, Germany
Research Site 1
Regensburg, 94053, Germany
Research Site 1
Rostock, 18057, Germany
Research Site 1
Soest, 59494, Germany
Research Site
Secunderabad, Andhra Pradesh, 500 003, India
Research Site
Mogappair, Chennai, 600037, India
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Naranpura, Gujarat, 380014, India
Research Site
Panjagutta, Hyderabad, 500082, India
Research Site 1
Coimbatore, India, India
Research Site 1
Madhya Pradesh, India, India
Research Site 1
Maharashtra, India, India
Research Site 1
Maharastra, India, India
Research Site 1
Rajasthan, India, India
Research Site
Bangalore, Karnataka, 560 034, India
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Bangalore, Karnataka, 560 054, India
Research Site
Bangalore, Karnataka, 560052, India
Research Site
College Road, Nashik, 422 005, India
Shree Saibaba Heart Institute and Research Centre
Shalimar, Nashik, 422 002, India
Sir Ganga Ram Hospital
New Delhi, New Delhi, India
Research Site
Bikaner, 334001, India
Research Site
Mumbai, 400 007, India
Research Site
New Delhi, 110025, India
Research Site
New Delhi, 110076, India
Sri Ramachandra Medical College of research Institute
Tamul Nadu, 600116, India
Research Site 1
Beersheba, Israel, 84101, Israel
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Haifa, Israel, 31048, Israel
Research Site 1
Holon, Israel, 58100, Israel
Research Site
Jerusalem, Israel, 91120, Israel
Research Site 1
Jerusalem, Israel, 91240, Israel
Research Site 1
Petah Tkva, Israel, Israel
Research Site 1
Safed, Safed, 13100, Israel
Research Site 1
Tel Aviv, Tel Aviv, 64239, Israel
Research Site 1
Haifa, 31048, Israel
Research Site 1
Jerusalem, 91004, Israel
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Brescia, Italy, 25123, Italy
Research Site 1
Piacenza, Italy, 29100, Italy
Research Site 1
Ravenna, Italy, Italy
Research Site 1
Pavia, Pavia, 27100, Italy
Research Site 1
Torino, Torino, 10126, Italy
Research Site 1
Bologna, 40138, Italy
Research Site 1
Cecina, 57023, Italy
Research Site 1
Cortina, 52044, Italy
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Genova, 16132, Italy
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Milan, 20132, Italy
Research Site 1
Novara, 28100, Italy
Research Site 1
Parma, 43100, Italy
Research Site 1
Pavia, 27100, Italy
Research Site 1
Roma, 00161, Italy
Azienda Ospedaliero-Universitaria "San Giovanni Battista di Torino" Struttura Complessa Cardiologia 1
Torino, 10126, Italy
Research Site
Curie 1, Nysa, 48-300, Poland
Research Site 1
Bydgoszcz, Poland, 85-168, Poland
Research Site
Starogard Gdański, Poland, Poland
Research Site 1
Bydgoszcz, 85-168, Poland
Research Site 1
Gdynia, 81-519, Poland
Research SIte
Kielce, 25-736, Poland
Research Site 1
Krakow, 31-121, Poland
Research Site 2
Krakow, 31-501, Poland
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Krakow, 31-913, Poland
Research Site
Lubartów, 21-100, Poland
Research Site 1
Ostrowiec Świętokrzyski, 27-400, Poland
Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej
Ostrołęka, 07-410, Poland
Research Site
Pabianice, 95-200, Poland
Samodzielnl Szpital Wojewodzki
Piotrkow Trybunalski, 97-300, Poland
Wojewodzki Szpital Specjalistczny w Radomiu, Oddzial Kardiologil
Radom, 26-617, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Sieradz, 98-200, Poland
Research Site 1
Torun, 87-100, Poland
Research Site 1
Warsaw, 00-909, Poland
Research Site 1
Warsaw, 01-211, Poland
Research Site 1
Warsaw, 02-005, Poland
Research Site 1
Warsaw, 02-507, Poland
Research Site 1
Warsaw, 02-637, Poland
Wojskowy Instytut Medyczny
Warsaw, 04-141, Poland
Research Site 1
Warsaw, 04-749, Poland
Research Site 1
Wroclaw, 50-367, Poland
Research Site 1
Wroclaw, 51-124, Poland
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Brasov, Romania, 500152, Romania
Research Site 1
Bucharest, Romania, 030572, Romania
Research Site 1
Tg Mures, Romania, 540136, Romania
Research Site 1
Bucharest, 014461, Romania
Research Site 1
Timișoara, 300310, Romania
Research Site 1
Lenskaya, Moscow, 129327, Russia
Research SIte 1
Moscow, Russia, 109240, Russia
Research Site 1
Moscow, Russia, 111020, Russia
Research SIte 1
Moscow, Russia, 115487, Russia
Research Site 1
Moscow, Russia, 115516, Russia
Research Site 1
Moscow, Russia, 119192, Russia
Research Site 1
Moscow, Russia, 119620, Russia
Research Site 1
Moscow, Russia, 121359, Russia
Research Site 1
Moscow, Russia, 123423, Russia
Research Site 1
Moscow, Russia, 125284, Russia
Research Site 1
Moscow, Russia, 127018, Russia
Research Site 1
Moscow, Russia, 127473, Russia
Research Site
Moscow, Russia, 129110, Russia
Research Site 1
Moscow, Russia, 129301, Russia
Research Site 1
Moscow, Russia, 129336, Russia
Research Site 1
Moscow, Russia, Russia
Research Site 1
Saint Petersburg, Russia, 192242, Russia
Research Site 1
Saint Petersburg, Russia, 194156, Russia
Research Site 1
Saint Petersburg, Russia, 196247, Russia
Research Site 1
Saint Petersburg, Russia, 197110, Russia
Research Site 1
Saint Petersburg, Russia, 199106, Russia
Research Site 1
L'va Tolstogo, Sankt-Peterburg, 197022, Russia
Research Site 1
Solidamosty, Sankt-Peterburg, 193312, Russia
Research Site 1
Saint Petersburg, 191187, Russia
Research Site 1
Bratislava, 826 06, Slovakia
Research Site 1
Nitra, 949 01, Slovakia
Interna klinika, Fakultna nemocnica Trencin
Trenčín, 91171, Slovakia
Research Site 1
Barcelona, 08003, Spain
Research Site 1
Barcelona, 08036, Spain
Research Site 1
Córdoba, 14004, Spain
Research Site 1
Madrid, 28007, Spain
Hospital Univeritario Virgen de la Victoria Servicio de Cardiologia
Málaga, 29010, Spain
Research Site 1
Málaga, 29010, Spain
Research Site 1
Santiago de Compostela, 15706, Spain
Research Site 1
Vigo, 36200, Spain
Research Site
Geneva, 1217, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 19, 2007
First Posted
December 21, 2007
Study Start
January 1, 2007
Primary Completion
June 1, 2010
Last Updated
June 28, 2011
Record last verified: 2010-11