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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00578695

Enrollment

652

Registered

2007-12-21

Start date

2007-01-31

Completion date

Unknown

Last updated

2011-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyponatremia

Keywords

Hyponatremia, Serum Sodium, Fluid Overload, Heart Failure, Acute Heart Failure, Vasopressin Antagonist

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.

Interventions

DRUGlixivaptan

Oral Capsule

DRUGPlacebo

Oral Capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Argentina, Canada, Chile, Czechia, Germany, India, Israel, Italy, Poland, Romania, Russia, Slovakia, Spain, Switzerland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026