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THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
This study is currently recruiting participants.
Verified by CardioKine Inc., January 2010
First Received: December 19, 2007   Last Updated: January 11, 2010   History of Changes
Sponsor: CardioKine Inc.
Collaborators: Cardiokine Biopharma, LLC
Biogen Idec
Information provided by: CardioKine Inc.
ClinicalTrials.gov Identifier: NCT00578695
  Purpose

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 Intervention Phase
Hyponatremia
Drug: lixivaptan
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation

Resource links provided by NLM:


Further study details as provided by CardioKine Inc.:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 650
Study Start Date: January 2007
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active: Experimental
Lixivaptan
Drug: lixivaptan
Oral Capsule
Placebo: Placebo Comparator
Placebo
Drug: Placebo
Oral Capsule

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00578695

Contacts
Contact: Cardiokine Inc, MD 215-399-1200

  Show 284 Study Locations
Sponsors and Collaborators
CardioKine Inc.
Cardiokine Biopharma, LLC
Biogen Idec
  More Information

No publications provided

Responsible Party: Cardiokine, Ink ( Cardiokine, Ink )
Study ID Numbers: CK-LX3401
Study First Received: December 19, 2007
Last Updated: January 11, 2010
ClinicalTrials.gov Identifier: NCT00578695     History of Changes
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on February 08, 2010