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Trial record 3 of 3 for:    Lixivaptan Heart Failure

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:
Cardiokine Biopharma, LLC
Biogen
Information provided by:
CardioKine Inc.

Tracking Information
First Submitted Date  ICMJE December 19, 2007
First Posted Date  ICMJE December 21, 2007
Last Update Posted Date June 28, 2011
Study Start Date  ICMJE January 2007
Actual Primary Completion Date June 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
Official Title  ICMJE THE 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hyponatremia
Intervention  ICMJE
  • Drug: lixivaptan
    Oral Capsule
  • Drug: Placebo
    Oral Capsule
Study Arms  ICMJE
  • Experimental: Active
    Lixivaptan
    Intervention: Drug: lixivaptan
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2011)
652
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2007)
650
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Canada,   Chile,   Czech Republic,   Germany,   India,   Israel,   Italy,   Poland,   Romania,   Russian Federation,   Slovakia,   Spain,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00578695
Other Study ID Numbers  ICMJE CK-LX3401
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Cardiokine, Ink
Original Responsible Party Cesare Orlandi, MD, Cardiokine Biopharma, LLC
Current Study Sponsor  ICMJE CardioKine Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Cardiokine Biopharma, LLC
  • Biogen
Investigators  ICMJE Not Provided
PRS Account CardioKine Inc.
Verification Date November 2010

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