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OpenTrials
Completed

NCT Number: NCT00578695

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

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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Key information

Conditions

Hyponatremia Cardiovascular Diseases Edema Heart Diseases Heart Failure Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Lixivaptan

Drug

Oral Capsule

Placebo

Drug

Oral Capsule

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

CardioKine Inc.

Industry

Collaborators

  • Biogen
  • Cardiokine Biopharma, LLC

Registry information

Important dates

Study start
2007
Primary completion
2010
First posted
Dec 21, 2007
Registry last updated
Jun 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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