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

This study has been completed.
Sponsor:
Collaborators:
Cardiokine Biopharma, LLC
Biogen Idec
Information provided by:
CardioKine Inc.
ClinicalTrials.gov Identifier:
NCT00578695
First received: December 19, 2007
Last updated: June 20, 2011
Last verified: November 2010

December 19, 2007
June 20, 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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Canada,   Chile,   Czech Republic,   Germany,   India,   Israel,   Italy,   Poland,   Romania,   Russian Federation,   Slovakia,   Spain,   Switzerland
 
NCT00578695
CK-LX3401
Yes
Cardiokine, Ink
CardioKine Inc.
  • Cardiokine Biopharma, LLC
  • Biogen Idec
Not Provided
CardioKine Inc.
November 2010

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