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


Tracking Information

Start Date  ICMJEJanuary 2007
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)		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 ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00578695 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
Original Secondary Outcome Measures ICMJE 

Descriptive Information

Brief Title  ICMJETHE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
Official Title  ICMJETHE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEHyponatremia
Intervention  ICMJE
  • Drug: lixivaptan
    Oral Capsule
  • Drug: Placebo
    Oral Capsule
Study Arms / Comparison Groups
  • Active: Experimental
    Lixivaptan
    Intervention: Drug: lixivaptan
  • Placebo: Placebo Comparator
    Placebo
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE650
Estimated Completion DateJuly 2010
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female patients 18 years of age or older with hyponatremia and hospitalized for congestive heart failure.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Cardiokine Inc, MD215-399-1200
Location Countries  ICMJEUnited States,   Argentina,   Canada,   Chile,   Czech Republic,   Germany,   India,   Israel,   Italy,   Poland,   Romania,   Russian Federation,   Slovakia,   Spain,   Switzerland

Administrative Information

NCT ID  ICMJENCT00578695
Responsible PartyCardiokine, Ink, Cardiokine, Ink
Study ID Numbers  ICMJECK-LX3401
Study Sponsor  ICMJECardioKine Inc.
Collaborators  ICMJE
  • Cardiokine Biopharma, LLC
  • Biogen Idec
Investigators  ICMJE 
Information Provided ByCardioKine Inc.