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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00578695
Recruitment Status : Completed
First Posted : December 21, 2007
Last Update Posted : June 28, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Hyponatremia Drug: lixivaptan Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 652 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : January 2007
Primary Completion Date : June 2010
Arms and Interventions

Arm Intervention/treatment
Experimental: Active
Lixivaptan
Drug: lixivaptan
Oral Capsule
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Oral Capsule


Outcome Measures

Primary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578695


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

Responsible Party: Cardiokine, Ink
ClinicalTrials.gov Identifier: NCT00578695     History of Changes
Other Study ID Numbers: CK-LX3401
First Posted: December 21, 2007    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: November 2010

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

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases