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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00578695
First Posted: December 21, 2007
Last Update Posted: June 28, 2011
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.
Collaborators:
Cardiokine Biopharma, LLC
Biogen
Information provided by:
CardioKine Inc.
December 19, 2007
December 21, 2007
June 28, 2011
January 2007
June 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00578695 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hyponatremia
  • Drug: lixivaptan
    Oral Capsule
  • Drug: Placebo
    Oral Capsule
  • Experimental: Active
    Lixivaptan
    Intervention: Drug: lixivaptan
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
652
Not Provided
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female patients 18 years of age or older with hyponatremia and hospitalized for congestive heart failure.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Canada,   Chile,   Czech Republic,   Germany,   India,   Israel,   Italy,   Poland,   Romania,   Russian Federation,   Slovakia,   Spain,   Switzerland,   United States
 
 
NCT00578695
CK-LX3401
Yes
Not Provided
Not Provided
Cardiokine, Ink
CardioKine Inc.
  • Cardiokine Biopharma, LLC
  • Biogen
Not Provided
CardioKine Inc.
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP