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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 ]

Enrollment: 652
Study Start Date: January 2007
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Lixivaptan
Drug: lixivaptan
Oral Capsule
Placebo Comparator: Placebo
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578695

  Show 285 Study Locations
Sponsors and Collaborators
CardioKine Inc.
Cardiokine Biopharma, LLC
Biogen Idec
  More Information

No publications provided

Responsible Party: Cardiokine, Ink
ClinicalTrials.gov Identifier: NCT00578695     History of Changes
Other Study ID Numbers: CK-LX3401
Study First Received: December 19, 2007
Last Updated: June 20, 2011
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:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014