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

CardioKine Inc.652 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

652

Conditions

Hyponatremia

Interventions

lixivaptanDRUG

Oral Capsule

PlaceboDRUG

Oral Capsule

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (287)

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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Research Site 1

Birmingham, Alabama, United States

Research Site 1

Birmingham, Alabama, United States

Research Site 1

Mobile, Alabama, United States

Research Site 1

Bakersfield, California, United States

Research Site 1

Banning, California, United States

Research Site 1

Glendale, California, United States

Research Site

Glendale, California, United States

Research Site 1

Los Angeles, California, United States

Research Site 1

Mission Viejo, California, United States

Research Site 1

Roseville, California, United States

...and 277 more locations