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

CardioKine

Status and phase: Completed; Phase 3

Conditions: Hyponatremia

Treatments: Drug: lixivaptan; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00578695

CK-LX3401

Details and patient eligibility

About

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.

Enrollment: 652 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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652 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Lixivaptan

Treatment:

Drug: lixivaptan

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo