Clinical trial NCT00578695: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyponatremia
Keywords: Hyponatremia
Serum Sodium
Fluid Overload
Heart Failure
Acute Heart Failure
Vasopressin Antagonist
Lead sponsor: CardioKine Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cardiokine Biopharma, LLC
name: Biogen
First posted: 2007-12-21
Enrollment: 652
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site 1
state: Alabama
city: Birmingham
country: United States
facility: Research Site 1
state: Alabama
city: Mobile
country: United States
facility: Research Site 1
state: Alabama
city: Bakersfield
country: United States
facility: Research Site 1
state: California
city: Banning
country: United States
facility: Research Site 1
state: California
city: Glendale
country: United States
facility: Research Site 1
state: California
city: Glendale
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site 1
state: California
city: Mission Viejo
country: United States
facility: Research Site 1
state: California
city: Roseville
country: United States
facility: Research Site 1
state: California
city: San Diego
country: United States
facility: Research Site 1
state: California
city: San Diego
country: United States
facility: Research Site 1
state: California
city: Aurora
country: United States
facility: Research Site 1
state: Colorado
city: Newark
country: United States
facility: Research Site 1
state: Delaware
city: Washington
country: United States
facility: Research Site 1
state: District of Columbia
city: Bay Pines
country: United States
facility: Research Site 1
state: Florida
city: Ft. Lauderdale
country: United States
facility: Research Site 1
state: Florida
city: Gainesville
country: United States
facility: Research Site 1
state: Florida
city: Jacksonville
country: United States
facility: Research Site 1
state: Florida
city: Jacksonville
country: United States
facility: Research Site 1
state: Florida
city: Jacksonville
country: United States
facility: Research Site 1
state: Florida
city: Lakeland
country: United States
facility: Research Site 1
state: Florida
city: Miami
country: United States
facility: Research Site 1
state: Florida
city: Port Charlotte
country: United States
facility: Research Site 1
state: Florida
city: Tampa
country: United States
facility: Research Site 1
state: Florida
city: Tampa
country: United States
facility: Research Site 1
state: Florida
city: Atlanta
country: United States
facility: Research Site 1
state: Georgia
city: Bannockburn
country: United States
facility: Research Site 1
state: Illinois
city: Chicago
country: United States
facility: Research Site 1
state: Illinois
city: Maywood
country: United States
facility: Research Site 1
state: Illinois
city: Normal
country: United States
facility: Research Site 1
state: Illinois
city: North Chicago
country: United States
facility: Research Site 1
state: Illinois
city: Oak Lawn
country: United States
facility: Research Site 1
state: Illinois
city: Peoria
country: United States
facility: Research Site 1
state: Illinois
city: Peoria
country: United States
facility: Research Site 1
state: Illinois
city: Munster
country: United States
facility: Research Site 1
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Iowa City
country: United States
facility: Research Site 1
state: Iowa
city: Louisville
country: United States
facility: Research Site 1
state: Kentucky
city: Louisville
country: United States
facility: Research Site 1
state: Kentucky
city: New Orleans
country: United States
facility: Research Site 1
state: Louisiana
city: Slidell
country: United States
facility: Research Site 1
state: Louisiana
city: Baltimore
country: United States
facility: Research Site 1
state: Maryland
city: Boston
country: United States
facility: Research Site 1
state: Massachusetts
city: Burlington
country: United States
facility: Research Site 1
state: Massachusetts
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Detroit
country: United States
facility: Research Site 1
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Petoskey
country: United States
facility: Research Site 1
state: Michigan
city: Traverse City
country: United States
facility: Research Site 1
state: Michigan
city: Duluth
country: United States
facility: Research Site 1
state: Minnesota
city: St. Louis
country: United States
facility: Research Site 1
state: Missouri
city: St. Louis
country: United States
facility: Research Site 1
state: Missouri
city: Lincoln
country: United States
facility: Research Site 1
state: Nebraska
city: Concord
country: United States
facility: Research Site 1
state: New Hampshire
city: Hackensack
country: United States
facility: Research Site 1
state: New Jersey
city: Livingston
country: United States
facility: Siant Barnabas Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Research Site 1
state: New Jersey
city: Newark
country: United States
facility: Research Site 1
state: New Jersey
city: Orange
country: United States
facility: Research Site 1
state: New Jersey
city: Paramus
country: United States
facility: Research Site 1
state: New Jersey
city: Bronx
country: United States
facility: Research Site 1
state: New York
city: Jamaica
country: United States
facility: Research Site 1
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Northport
country: United States
facility: Research Site 1
state: New York
city: Stony Brook
country: United States
facility: Research Site 1
state: New York
city: Valhalla
country: United States
facility: Research Site 1
state: New York
city: Winston-Salem
country: United States
facility: Research Site 1
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site 1
state: Ohio
city: Columbus
country: United States
facility: Research Site 1
state: Ohio
city: Fairfield
country: United States
facility: Research Site 1
state: Ohio
city: Fairfield
country: United States
facility: Research Site
state: Ohio
city: Middletown
country: United States
facility: Research Site 1
state: Ohio
city: Toledo
country: United States
facility: Research Site 1
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site 1
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site 2
state: Oklahoma
city: Tulsa
country: United States
facility: Research Site 1
state: Oklahoma
city: Springfield
country: United States
facility: Research Site 1
state: Oregon
city: Beaver
country: United States
facility: Research Site 1
state: Pennsylvania
city: Camp Hill
country: United States
facility: Research Site 1
state: Pennsylvania
city: Danville
country: United States
facility: Research Site 1
state: Pennsylvania
city: Pittsburg
country: United States
facility: Research Site 1
state: Pennsylvania
city: Sayre
country: United States
facility: Research Site1
state: Pennsylvania
city: Sellersville
country: United States
facility: Research Site 1
state: Pennsylvania
city: Chattanooga
country: United States
facility: Research Site 1
state: Tennessee
city: Germantown
country: United States
facility: Research Site 1
state: Tennessee
city: Nashville
country: United States
facility: Research Site 1
state: Tennessee
city: Amarillo
country: United States
facility: Research Site 1
state: Texas
city: Dallas
country: United States
facility: Research Site 1
state: Texas
city: Dallas
country: United States
facility: Research Site 1
state: Texas
city: Galveston
country: United States
facility: Research Site 1
state: Texas
city: Houston
country: United States
facility: Research Site 1
state: Texas
city: Houston
country: United States
facility: Research Site 1
state: Texas
city: Lubbock
country: United States
facility: Research Site 1
state: Texas
city: Temple
country: United States
facility: Research Site 1
state: Texas
city: Tyler
country: United States
facility: Research Site 1
state: Texas
city: Chesapeake
country: United States
facility: Research Site 1
state: Virginia
city: Richmond
country: United States
facility: Research Site 2
state: Virginia
city: Richmond
country: United States
facility: Research Site 1
state: Virginia
city: Seattle
country: United States
facility: Research Site 1
state: Washington
city: Beloit
country: United States
facility: Research Site 1
state: Wisconsin
city: Madison
country: United States
facility: Research Site 1
state: Wisconsin
city: San Martin
country: Argentina
facility: hospital Interzonal General de Agudos, "Eva Peron" (HIGA)
state: Buenos Aires
city: Ciudad Autonomo de Buenos Aires
country: Argentina
facility: Research Site
state: Galvan
city: Rosario
country: Argentina
facility: Research Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Research Site
city: Buenos Aires
country: Argentina
facility: Research Site
city: Buenos Aires
country: Argentina
facility: Research Site 1
city: Buenos Aires
country: Argentina
facility: Research Site 1
city: Buenos Aires
country: Argentina
facility: Research Site 1
city: Buenos Aires
country: Argentina
facility: Research Site 1
city: Buenos Aires
country: Argentina
facility: Research Site 1
city: Buenos Aires
country: Argentina
facility: Research Site 1
city: Buenos Aires
country: Argentina
facility: Hospital Militar Central H Gral. 601 "Cirujano Mayor Dr. Cosme Argerich"
city: Buenos Aires
country: Argentina
facility: Hospital de Clinicas "Jose de San Martin"
city: Cerrientes
country: Argentina
facility: Research Site 1
city: Provincia de Buenos Aires
country: Argentina
facility: Research Site 1
city: Provincia de Misiones
country: Argentina
facility: Research Site 1
city: Provincia de Santa Fe
country: Argentina
facility: Research Site 1
city: Tucuman
country: Argentina
facility: Research Site 1
city: Kitchener
country: Canada
facility: Research Site 1
state: Ontario
city: Ottawa
country: Canada
facility: Research Site 1
state: Ontario
city: Scarborough
country: Canada
facility: Research Site 1
state: Ontario
city: Toronto
country: Canada
facility: Research Site 1
state: Ontario
city: Montreal
country: Canada
facility: Research Site 1
state: Quebec
city: Montreal
country: Canada
facility: Research Site 1
state: Quebec
city: Sherbrooke
country: Canada
facility: Research Site 1
state: Quebec
city: St. Jerome
country: Canada
facility: Research Site 1
state: Quebec
city: Manitoba
country: Canada
facility: Research Site 1
city: New Brunswick
country: Canada
facility: Research Site 1
city: Quebec
country: Canada
facility: Research Site 1
city: Quebec
country: Canada
facility: Research Site 1
city: Vancouver
country: Canada
facility: Research Site 1
city: Antofagasta
country: Chile
facility: Research Site 1
city: Concepcion
country: Chile
facility: Research Site 1
city: Orosno
country: Chile
facility: Research Site 1
city: Puerto Montt
country: Chile
facility: Hospital de Puerto Montt
city: Santiago
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site 1
city: Santiago
country: Chile
facility: Research Site 1
city: Temuco
country: Chile
facility: Research Site
city: Vina del Mar
country: Chile
facility: Research Site 1
city: Havlickuv Brod
country: Czech Republic
facility: Research Site 1
city: Kladno
country: Czech Republic
facility: Research Site 1
city: Kromeriz
country: Czech Republic
facility: Research Site 1
city: Liberec
country: Czech Republic
facility: Research Site 1
city: Mestec Kralove
country: Czech Republic
facility: Research Site 1
city: Ostrava
country: Czech Republic
facility: Research Site 1
city: Praha 1
country: Czech Republic
facility: Research Site 1
city: Praha 2
country: Czech Republic
facility: Research Site 1
city: Praha
country: Czech Republic
facility: Research Site 1
city: Praha
country: Czech Republic
facility: Research Site 1
city: Pribram
country: Czech Republic
facility: Research Site 1
city: Znojmo
country: Czech Republic
facility: Research Site 1
city: Bad Krozingen
country: Germany
facility: Research Site 1
city: Bad Nauheim
country: Germany
facility: Research Site 1
city: Bad Segeberg
country: Germany
facility: Research Site 1
city: Berlin
country: Germany
facility: Research Site 1
city: Berlin
country: Germany
facility: Research Site 1
city: Bonn
country: Germany
facility: Research Site 1
city: Coburg
country: Germany
facility: Research Site 1
city: Dresden
country: Germany
facility: Research Site 1
city: Gottingen
country: Germany
facility: Research Site 1
city: Greifswald
country: Germany
facility: Research Site 1
city: Hamburg
country: Germany
facility: Research Site 1
city: Hannover
country: Germany
facility: Research Site 1
city: Hannover
country: Germany
facility: Research Site 1
city: Jena
country: Germany
facility: Research Site 1
city: Karisbad
country: Germany
facility: Research Site 1
city: Konstanz
country: Germany
facility: Research Site 1
city: Leipzig
country: Germany
facility: Research Site 1
city: Regensburg
country: Germany
facility: Research Site 1
city: Regensburg
country: Germany
facility: Research Site 1
city: Rostock
country: Germany
facility: Research Site 1
city: Soest
country: Germany
facility: Research Site 1
city: Secunderabad
country: India
facility: Research Site
state: Andhra Pradesh
city: Mogappair
country: India
facility: Research Site
state: Chennai
city: Naranpura
country: India
facility: Research Site
state: Gujarat
city: Panjagutta
country: India
facility: Research Site
state: Hyderabad
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: College Road
country: India
facility: Research Site
state: Nashik
city: Shalimar
country: India
facility: Shree Saibaba Heart Institute and Research Centre
state: Nashik
city: Bikaner
country: India
facility: Research Site
city: Coimbatore
country: India
facility: Research Site 1
city: Madhya Pradesh
country: India
facility: Research Site 1
city: Maharashtra
country: India
facility: Research Site 1
city: Maharastra
country: India
facility: Research Site 1
city: Mumbai
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: Rajasthan
country: India
facility: Research Site 1
city: Tamul Nadu
country: India
facility: Sri Ramachandra Medical College of research Institute
city: Be'er-Sheva
country: Israel
facility: Research Site 1
city: Haifa
country: Israel
facility: Research Site 1
city: Haifa
country: Israel
facility: Research Site
city: Holon
country: Israel
facility: Research Site 1
city: Jerusalem
country: Israel
facility: Research Site 1
city: Jerusalem
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site 1
city: Petah Tkva
country: Israel
facility: Research Site 1
city: Safed
country: Israel
facility: Research Site 1
city: Tel Aviv
country: Israel
facility: Research Site 1
city: Bologna
country: Italy
facility: Research Site 1
city: Brescia
country: Italy
facility: Research Site
city: Cecina
country: Italy
facility: Research Site 1
city: Cortina
country: Italy
facility: Research Site 1
city: Genova
country: Italy
facility: Research Site 1
city: Milano
country: Italy
facility: Research Site 1
city: Novara
country: Italy
facility: Research Site 1
city: Parma
country: Italy
facility: Research Site 1
city: Pavia
country: Italy
facility: Research Site 1
city: Piacenza
country: Italy
facility: Research Site 1
city: Ravenna
country: Italy
facility: Research Site 1
city: Roma
country: Italy
facility: Research Site 1
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria "San Giovanni Battista di Torino" Struttura Complessa Cardiologia 1
city: Torino
country: Italy
facility: Research Site 1
city: Curie 1
country: Poland
facility: Research Site
state: Nysa
city: Bydgoszcz
country: Poland
facility: Research Site 1
city: Gdynia
country: Poland
facility: Research Site 1
city: Kielce
country: Poland
facility: Research SIte
city: Krakow
country: Poland
facility: Research Site 1
city: Krakow
country: Poland
facility: Research Site 2
city: Krakow
country: Poland
facility: Research Site
city: Lubartow
country: Poland
facility: Research Site
city: Ostroleka
country: Poland
facility: Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej
city: Ostrowiec Swietokrzyski
country: Poland
facility: Research Site 1
city: Pabianice
country: Poland
facility: Research Site
city: Piotrkow Trybunalski
country: Poland
facility: Samodzielnl Szpital Wojewodzki
city: Radom
country: Poland
facility: Wojewodzki Szpital Specjalistczny w Radomiu, Oddzial Kardiologil
city: Sieradz
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej
city: Starogard Gdanski
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site 1
city: Warszawa
country: Poland
facility: Research Site 1
city: Warszawa
country: Poland
facility: Research Site 1
city: Warszawa
country: Poland
facility: Research Site 1
city: Warszawa
country: Poland
facility: Research Site 1
city: Warszawa
country: Poland
facility: Research Site 1
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
city: Warszawa
country: Poland
facility: Research Site 1
city: Wroclaw
country: Poland
facility: Research Site 1
city: Wroclaw
country: Poland
facility: Research Site 1
city: Brasov
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site 1
city: Bucharest
country: Romania
facility: Research Site 1
city: Tg Mures
country: Romania
facility: Research Site 1
city: Timisoara
country: Romania
facility: Research Site 1
city: Lenskaya
country: Russian Federation
facility: Research Site 1
state: Moscow
city: Moscow
country: Russian Federation
facility: Research SIte 1
state: Russia
city: Moscow
country: Russian Federation
facility: Research Site 1
state: Russia
city: Moscow
country: Russian Federation
facility: Research SIte 1
state: Russia
city: Moscow
country: Russian Federation
facility: Research Site 1
state: Russia
city: Moscow
country: Russian Federation
facility: Research Site 1
state: Russia
city: Moscow
country: Russian Federation
facility: Research Site 1
state: Russia
city: Moscow
country: Russian Federation
facility: Research Site 1
state: Russia
city: Moscow
country: Russian Federation
facility: Research Site 1
state: Russia
city: Moscow
country: Russian Federation
facility: Research Site 1
state: Russia
city: Moscow
country: Russian Federation
facility: Research Site 1
state: Russia
city: Moscow
country: Russian Federation
facility: Research Site 1
state: Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Russia
city: Moscow
country: Russian Federation
facility: Research Site 1
state: Russia
city: Moscow
country: Russian Federation
facility: Research Site 1
state: Russia
city: Moscow
country: Russian Federation
facility: Research Site 1
state: Russia
city: Saint-Petersburg
country: Russian Federation
facility: Research Site 1
state: Russia
city: Saint-Petersburg
country: Russian Federation
facility: Research Site 1
state: Russia
city: Saint-Petersburg
country: Russian Federation
facility: Research Site 1
state: Russia
city: Saint-Petersburg
country: Russian Federation
facility: Research Site 1
state: Russia
city: Saint-Petersburg
country: Russian Federation
facility: Research Site 1
state: Russia
city: L'va Tolstogo
country: Russian Federation
facility: Research Site 1
state: Saint-Petersburg
city: Solidamosty
country: Russian Federation
facility: Research Site 1
state: Saint-Petersburg
city: Saint Petersburg
country: Russian Federation
facility: Research Site 1
city: Bratislava
country: Slovakia
facility: Research Site 1
city: Nitra
country: Slovakia
facility: Research Site 1
city: Trencin
country: Slovakia
facility: Interna klinika, Fakultna nemocnica Trencin
city: Barcelona
country: Spain
facility: Research Site 1
city: Barcelona
country: Spain
facility: Research Site 1
city: Cordoba
country: Spain
facility: Research Site 1
city: Madrid
country: Spain
facility: Research Site 1
city: Malaga
country: Spain
facility: Hospital Univeritario Virgen de la Victoria Servicio de Cardiologia
city: Malaga
country: Spain
facility: Research Site 1
city: Santiago de Compostela
country: Spain
facility: Research Site 1
city: Vigo
country: Spain
facility: Research Site 1
city: Geneva
country: Switzerland
facility: Research Site
Study officials:
References: