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THE BALANCE Study: Treatment ...

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

Last Updated: 2011-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

652 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyponatremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active

Lixivaptan

Group Type EXPERIMENTAL

lixivaptan

Intervention Type DRUG

Oral Capsule

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral Capsule

Interventions

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lixivaptan

Oral Capsule

Intervention Type DRUG

Placebo

Oral Capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Cardiokine, Ink

Locations

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Research Site 1

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Bakersfield, California, United States

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Banning, California, United States

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Glendale, California, United States

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Glendale, California, United States

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Los Angeles, California, United States

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Mission Viejo, California, United States

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Roseville, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Aurora, Colorado, United States

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Newark, Delaware, United States

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Washington D.C., District of Columbia, United States

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Bay Pines, Florida, United States

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Fort Lauderdale, Florida, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Lakeland, Florida, United States

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Miami, Florida, United States

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Port Charlotte, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Bannockburn, Illinois, United States

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Chicago, Illinois, United States

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Maywood, Illinois, United States

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Normal, Illinois, United States

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North Chicago, Illinois, United States

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Oak Lawn, Illinois, United States

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Peoria, Illinois, United States

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Peoria, Illinois, United States

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Munster, Indiana, United States

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University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

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Iowa City, Iowa, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Slidell, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Burlington, Massachusetts, United States

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Detroit, Michigan, United States

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Research Site 1

Detroit, Michigan, United States

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Northern Michigan Hospital

Petoskey, Michigan, United States

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Petoskey, Michigan, United States

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Traverse City, Michigan, United States

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Duluth, Minnesota, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Concord, New Hampshire, United States

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Hackensack, New Jersey, United States

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Siant Barnabas Medical Center

Livingston, New Jersey, United States

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Morristown, New Jersey, United States

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Newark, New Jersey, United States

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Orange, New Jersey, United States

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Paramus, New Jersey, United States

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Jamaica, New York, United States

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New York, New York, United States

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Northport, New York, United States

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Stony Brook, New York, United States

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The Bronx, New York, United States

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Valhalla, New York, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Fairfield, Ohio, United States

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Fairfield, Ohio, United States

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Middletown, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Springfield, Oregon, United States

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Beaver, Pennsylvania, United States

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Camp Hill, Pennsylvania, United States

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Danville, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Sayre, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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Chattanooga, Tennessee, United States

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Germantown, Tennessee, United States

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Nashville, Tennessee, United States

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Amarillo, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Galveston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Lubbock, Texas, United States

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Temple, Texas, United States

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Tyler, Texas, United States

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Chesapeake, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Beloit, Wisconsin, United States

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