Hyponatremia Clinical Trial
Official title:
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
| NCT number | NCT00578695 |
| Other study ID # | CK-LX3401 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | December 19, 2007 |
| Last updated | June 20, 2011 |
| Start date | January 2007 |
| Verified date | November 2010 |
| Source | CardioKine Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 652 |
| Est. completion date | |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Male and female patients 18 years of age or older with hyponatremia and hospitalized for congestive heart failure. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital de Clinicas "Jose de San Martin" | Buenos Aires | |
| Argentina | Hospital Militar Central H Gral. 601 "Cirujano Mayor Dr. Cosme Argerich" | Buenos Aires | |
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site 1 | Buenos Aires | |
| Argentina | Research Site 1 | Buenos Aires | |
| Argentina | Research Site 1 | Buenos Aires | |
| Argentina | Research Site 1 | Buenos Aires | |
| Argentina | Research Site 1 | Buenos Aires | |
| Argentina | Research Site 1 | Buenos Aires | |
| Argentina | Research Site 1 | Cerrientes | |
| Argentina | Research Site | Ciudad Autonomo de Buenos Aires | Galvan |
| Argentina | Research Site 1 | Provincia de Buenos Aires | |
| Argentina | Research Site 1 | Provincia de Misiones | |
| Argentina | Research Site 1 | Provincia de Santa Fe | |
| Argentina | Research Site | Rosario | Santa Fe |
| Argentina | hospital Interzonal General de Agudos, "Eva Peron" (HIGA) | San Martin | Buenos Aires |
| Argentina | Research Site 1 | Tucuman | |
| Canada | Research Site 1 | Kitchener | Ontario |
| Canada | Research Site 1 | Manitoba | |
| Canada | Research Site 1 | Montreal | Quebec |
| Canada | Research Site 1 | Montreal | Quebec |
| Canada | Research Site 1 | New Brunswick | |
| Canada | Research Site 1 | Ottawa | Ontario |
| Canada | Research Site 1 | Quebec | |
| Canada | Research Site 1 | Quebec | |
| Canada | Research Site 1 | Scarborough | Ontario |
| Canada | Research Site 1 | Sherbrooke | Quebec |
| Canada | Research Site 1 | St. Jerome | Quebec |
| Canada | Research Site 1 | Toronto | Ontario |
| Canada | Research Site 1 | Vancouver | |
| Chile | Research Site 1 | Antofagasta | |
| Chile | Research Site 1 | Concepcion | |
| Chile | Research Site 1 | Orosno | |
| Chile | Hospital de Puerto Montt | Puerto Montt | |
| Chile | Research Site | Santiago | |
| Chile | Research Site 1 | Santiago | |
| Chile | Research Site 1 | Santiago | |
| Chile | Research Site | Temuco | |
| Chile | Research Site 1 | Vina del Mar | |
| Czech Republic | Research Site 1 | Havlickuv Brod | |
| Czech Republic | Research Site 1 | Kladno | |
| Czech Republic | Research Site 1 | Kromeriz | |
| Czech Republic | Research Site 1 | Liberec | |
| Czech Republic | Research Site 1 | Mestec Kralove | |
| Czech Republic | Research Site 1 | Ostrava | |
| Czech Republic | Research Site 1 | Praha | |
| Czech Republic | Research Site 1 | Praha | |
| Czech Republic | Research Site 1 | Praha 1 | |
| Czech Republic | Research Site 1 | Praha 2 | |
| Czech Republic | Research Site 1 | Pribram | |
| Czech Republic | Research Site 1 | Znojmo | |
| Germany | Research Site 1 | Bad Krozingen | |
| Germany | Research Site 1 | Bad Nauheim | |
| Germany | Research Site 1 | Bad Segeberg | |
| Germany | Research Site 1 | Berlin | |
| Germany | Research Site 1 | Berlin | |
| Germany | Research Site 1 | Bonn | |
| Germany | Research Site 1 | Coburg | |
| Germany | Research Site 1 | Dresden | |
| Germany | Research Site 1 | Gottingen | |
| Germany | Research Site 1 | Greifswald | |
| Germany | Research Site 1 | Hamburg | |
| Germany | Research Site 1 | Hannover | |
| Germany | Research Site 1 | Hannover | |
| Germany | Research Site 1 | Jena | |
| Germany | Research Site 1 | Karisbad | |
| Germany | Research Site 1 | Konstanz | |
| Germany | Research Site 1 | Leipzig | |
| Germany | Research Site 1 | Regensburg | |
| Germany | Research Site 1 | Regensburg | |
| Germany | Research Site 1 | Rostock | |
| Germany | Research Site 1 | Soest | |
| India | Research Site | Bangalore | Karnataka |
| India | Research Site | Bangalore | Karnataka |
| India | Research Site | Bangalore | Karnataka |
| India | Research Site | Bikaner | |
| India | Research Site 1 | Coimbatore | |
| India | Research Site | College Road | Nashik |
| India | Research Site 1 | Madhya Pradesh | |
| India | Research Site 1 | Maharashtra | |
| India | Research Site 1 | Maharastra | |
| India | Research Site | Mogappair | Chennai |
| India | Research Site | Mumbai | |
| India | Research Site | Naranpura | Gujarat |
| India | Research Site | New Delhi | |
| India | Research Site | New Delhi | |
| India | Sir Ganga Ram Hospital | New Delhi | |
| India | Research Site | Panjagutta | Hyderabad |
| India | Research Site 1 | Rajasthan | |
| India | Research Site | Secunderabad | Andhra Pradesh |
| India | Shree Saibaba Heart Institute and Research Centre | Shalimar | Nashik |
| India | Sri Ramachandra Medical College of research Institute | Tamul Nadu | |
| Israel | Research Site 1 | Be'er-Sheva | |
| Israel | Research Site | Haifa | |
| Israel | Research Site 1 | Haifa | |
| Israel | Research Site 1 | Holon | |
| Israel | Research Site | Jerusalem | |
| Israel | Research Site 1 | Jerusalem | |
| Israel | Research Site 1 | Jerusalem | |
| Israel | Research Site 1 | Petah Tkva | |
| Israel | Research Site 1 | Safed | |
| Israel | Research Site 1 | Tel Aviv | |
| Italy | Research Site 1 | Bologna | |
| Italy | Research Site | Brescia | |
| Italy | Research Site 1 | Cecina | |
| Italy | Research Site 1 | Cortina | |
| Italy | Research Site 1 | Genova | |
| Italy | Research Site 1 | Milano | |
| Italy | Research Site 1 | Novara | |
| Italy | Research Site 1 | Parma | |
| Italy | Research Site 1 | Pavia | |
| Italy | Research Site 1 | Piacenza | |
| Italy | Research Site 1 | Ravenna | |
| Italy | Research Site 1 | Roma | |
| Italy | Azienda Ospedaliero-Universitaria "San Giovanni Battista di Torino" Struttura Complessa Cardiologia 1 | Torino | |
| Italy | Research Site 1 | Torino | |
| Poland | Research Site 1 | Bydgoszcz | |
| Poland | Research Site | Curie 1 | Nysa |
| Poland | Research Site 1 | Gdynia | |
| Poland | Research SIte | Kielce | |
| Poland | Research Site | Krakow | |
| Poland | Research Site 1 | Krakow | |
| Poland | Research Site 2 | Krakow | |
| Poland | Research Site | Lubartow | |
| Poland | Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej | Ostroleka | |
| Poland | Research Site 1 | Ostrowiec Swietokrzyski | |
| Poland | Research Site | Pabianice | |
| Poland | Samodzielnl Szpital Wojewodzki | Piotrkow Trybunalski | |
| Poland | Wojewodzki Szpital Specjalistczny w Radomiu, Oddzial Kardiologil | Radom | |
| Poland | Samodzielny Publiczny Zaklad Opieki Zdrowotnej | Sieradz | |
| Poland | Research Site | Starogard Gdanski | |
| Poland | Research Site 1 | Torun | |
| Poland | Research Site 1 | Warszawa | |
| Poland | Research Site 1 | Warszawa | |
| Poland | Research Site 1 | Warszawa | |
| Poland | Research Site 1 | Warszawa | |
| Poland | Research Site 1 | Warszawa | |
| Poland | Research Site 1 | Warszawa | |
| Poland | Wojskowy Instytut Medyczny | Warszawa | |
| Poland | Research Site 1 | Wroclaw | |
| Poland | Research Site 1 | Wroclaw | |
| Romania | Research Site | Brasov | |
| Romania | Research Site 1 | Bucharest | |
| Romania | Research Site 1 | Bucharest | |
| Romania | Research Site 1 | Tg Mures | |
| Romania | Research Site 1 | Timisoara | |
| Russian Federation | Research Site 1 | L'va Tolstogo | Saint-Petersburg |
| Russian Federation | Research Site 1 | Lenskaya | Moscow |
| Russian Federation | Research Site | Moscow | Russia |
| Russian Federation | Research Site 1 | Moscow | Russia |
| Russian Federation | Research Site 1 | Moscow | Russia |
| Russian Federation | Research Site 1 | Moscow | Russia |
| Russian Federation | Research SIte 1 | Moscow | Russia |
| Russian Federation | Research Site 1 | Moscow | Russia |
| Russian Federation | Research SIte 1 | Moscow | Russia |
| Russian Federation | Research Site 1 | Moscow | Russia |
| Russian Federation | Research Site 1 | Moscow | Russia |
| Russian Federation | Research Site 1 | Moscow | Russia |
| Russian Federation | Research Site 1 | Moscow | Russia |
| Russian Federation | Research Site 1 | Moscow | Russia |
| Russian Federation | Research Site 1 | Moscow | Russia |
| Russian Federation | Research Site 1 | Moscow | Russia |
| Russian Federation | Research Site 1 | Moscow | Russia |
| Russian Federation | Research Site 1 | Saint Petersburg | |
| Russian Federation | Research Site 1 | Saint-Petersburg | Russia |
| Russian Federation | Research Site 1 | Saint-Petersburg | Russia |
| Russian Federation | Research Site 1 | Saint-Petersburg | Russia |
| Russian Federation | Research Site 1 | Saint-Petersburg | Russia |
| Russian Federation | Research Site 1 | Saint-Petersburg | Russia |
| Russian Federation | Research Site 1 | Solidamosty | Saint-Petersburg |
| Slovakia | Research Site 1 | Bratislava | |
| Slovakia | Research Site 1 | Nitra | |
| Slovakia | Interna klinika, Fakultna nemocnica Trencin | Trencin | |
| Spain | Research Site 1 | Barcelona | |
| Spain | Research Site 1 | Barcelona | |
| Spain | Research Site 1 | Cordoba | |
| Spain | Research Site 1 | Madrid | |
| Spain | Hospital Univeritario Virgen de la Victoria Servicio de Cardiologia | Malaga | |
| Spain | Research Site 1 | Malaga | |
| Spain | Research Site 1 | Santiago de Compostela | |
| Spain | Research Site 1 | Vigo | |
| Switzerland | Research Site | Geneva | |
| United States | Research Site 1 | Amarillo | Texas |
| United States | Research Site 1 | Atlanta | Georgia |
| United States | Research Site 1 | Aurora | Colorado |
| United States | Research Site 1 | Bakersfield | California |
| United States | Research Site 1 | Baltimore | Maryland |
| United States | Research Site 1 | Banning | California |
| United States | Research Site 1 | Bannockburn | Illinois |
| United States | Research Site 1 | Bay Pines | Florida |
| United States | Research Site 1 | Beaver | Pennsylvania |
| United States | Research Site 1 | Beloit | Wisconsin |
| United States | Research Site 1 | Birmingham | Alabama |
| United States | Research Site 1 | Birmingham | Alabama |
| United States | Research Site 1 | Boston | Massachusetts |
| United States | Research Site 1 | Bronx | New York |
| United States | Research Site 1 | Burlington | Massachusetts |
| United States | Research Site 1 | Camp Hill | Pennsylvania |
| United States | Research Site 1 | Chattanooga | Tennessee |
| United States | Research Site 1 | Chesapeake | Virginia |
| United States | Research Site 1 | Chicago | Illinois |
| United States | Research Site 1 | Cincinnati | Ohio |
| United States | Research Site 1 | Columbus | Ohio |
| United States | Research Site 1 | Concord | New Hampshire |
| United States | Research Site 1 | Dallas | Texas |
| United States | Research Site 1 | Dallas | Texas |
| United States | Research Site 1 | Danville | Pennsylvania |
| United States | Research Site | Detroit | Michigan |
| United States | Research Site 1 | Detroit | Michigan |
| United States | Research Site 1 | Duluth | Minnesota |
| United States | Research Site | Fairfield | Ohio |
| United States | Research Site 1 | Fairfield | Ohio |
| United States | Research Site 1 | Ft. Lauderdale | Florida |
| United States | Research Site 1 | Gainesville | Florida |
| United States | Research Site 1 | Galveston | Texas |
| United States | Research Site 1 | Germantown | Tennessee |
| United States | Research Site | Glendale | California |
| United States | Research Site 1 | Glendale | California |
| United States | Research Site 1 | Hackensack | New Jersey |
| United States | Research Site 1 | Houston | Texas |
| United States | Research Site 1 | Houston | Texas |
| United States | Research Site 1 | Iowa City | Iowa |
| United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
| United States | Research Site 1 | Jacksonville | Florida |
| United States | Research Site 1 | Jacksonville | Florida |
| United States | Research Site 1 | Jacksonville | Florida |
| United States | Research Site 1 | Jamaica | New York |
| United States | Research Site 1 | Lakeland | Florida |
| United States | Research Site 1 | Lincoln | Nebraska |
| United States | Siant Barnabas Medical Center | Livingston | New Jersey |
| United States | Research Site 1 | Los Angeles | California |
| United States | Research Site 1 | Louisville | Kentucky |
| United States | Research Site 1 | Louisville | Kentucky |
| United States | Research Site 1 | Lubbock | Texas |
| United States | Research Site 1 | Madison | Wisconsin |
| United States | Research Site 1 | Maywood | Illinois |
| United States | Research Site 1 | Miami | Florida |
| United States | Research Site 1 | Middletown | Ohio |
| United States | Research Site 1 | Mission Viejo | California |
| United States | Research Site 1 | Mobile | Alabama |
| United States | Research Site 1 | Morristown | New Jersey |
| United States | Research Site 1 | Munster | Indiana |
| United States | Research Site 1 | Nashville | Tennessee |
| United States | Research Site 1 | New Orleans | Louisiana |
| United States | Research Site | New York | New York |
| United States | Research Site 1 | Newark | New Jersey |
| United States | Research Site 1 | Newark | Delaware |
| United States | Research Site 1 | Normal | Illinois |
| United States | Research Site 1 | North Chicago | Illinois |
| United States | Research Site 1 | Northport | New York |
| United States | Research Site 1 | Oak Lawn | Illinois |
| United States | Research Site 1 | Oklahoma City | Oklahoma |
| United States | Research Site 2 | Oklahoma City | Oklahoma |
| United States | Research Site 1 | Orange | New Jersey |
| United States | Research Site 1 | Paramus | New Jersey |
| United States | Research Site 1 | Peoria | Illinois |
| United States | Research Site 1 | Peoria | Illinois |
| United States | Northern Michigan Hospital | Petoskey | Michigan |
| United States | Research Site 1 | Petoskey | Michigan |
| United States | Research Site 1 | Pittsburg | Pennsylvania |
| United States | Research Site 1 | Port Charlotte | Florida |
| United States | Research Site 1 | Richmond | Virginia |
| United States | Research Site 2 | Richmond | Virginia |
| United States | Research Site 1 | Roseville | California |
| United States | Research Site 1 | San Diego | California |
| United States | Research Site 1 | San Diego | California |
| United States | Research Site1 | Sayre | Pennsylvania |
| United States | Research Site 1 | Seattle | Washington |
| United States | Research Site 1 | Sellersville | Pennsylvania |
| United States | Research Site 1 | Slidell | Louisiana |
| United States | Research Site 1 | Springfield | Oregon |
| United States | Research Site 1 | St. Louis | Missouri |
| United States | Research Site 1 | St. Louis | Missouri |
| United States | Research Site 1 | Stony Brook | New York |
| United States | Research Site 1 | Tampa | Florida |
| United States | Research Site 1 | Tampa | Florida |
| United States | Research Site 1 | Temple | Texas |
| United States | Research Site 1 | Toledo | Ohio |
| United States | Research Site 1 | Traverse City | Michigan |
| United States | Research Site 1 | Tulsa | Oklahoma |
| United States | Research Site 1 | Tyler | Texas |
| United States | Research Site 1 | Valhalla | New York |
| United States | Research Site 1 | Washington | District of Columbia |
| United States | Research Site 1 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| CardioKine Inc. | Biogen, Cardiokine Biopharma, LLC |
United States, Argentina, Canada, Chile, Czech Republic, Germany, India, Israel, Italy, Poland, Romania, Russian Federation, Slovakia, Spain, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
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