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

This study has been completed.
Cardiokine Biopharma, LLC
Information provided by:
CardioKine Inc. Identifier:
First received: December 19, 2007
Last updated: June 20, 2011
Last verified: November 2010
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.

Condition Intervention Phase
Drug: lixivaptan
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation

Further study details as provided by CardioKine Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 652
Study Start Date: January 2007
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Drug: lixivaptan
Oral Capsule
Placebo Comparator: Placebo
Drug: Placebo
Oral Capsule


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female patients 18 years of age or older with hyponatremia and hospitalized for congestive heart failure.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00578695

  Show 285 Study Locations
Sponsors and Collaborators
CardioKine Inc.
Cardiokine Biopharma, LLC
  More Information

Responsible Party: Cardiokine, Ink Identifier: NCT00578695     History of Changes
Other Study ID Numbers: CK-LX3401
Study First Received: December 19, 2007
Last Updated: June 20, 2011

Keywords provided by CardioKine Inc.:
Serum Sodium
Fluid Overload
Heart Failure
Acute Heart Failure
Vasopressin Antagonist

Additional relevant MeSH terms:
Water-Electrolyte Imbalance
Metabolic Diseases processed this record on May 25, 2017