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Trial record 3 of 3 for:    Lixivaptan Heart Failure
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THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation

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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hyponatremia Drug: lixivaptan Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 652 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : January 2007
Actual Primary Completion Date : June 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Active
Lixivaptan
 Drug: lixivaptan
Oral Capsule
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Oral Capsule


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578695


Locations
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Sponsors and Collaborators
CardioKine Inc.
Cardiokine Biopharma, LLC
Biogen
More Information
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Responsible Party: Cardiokine, Ink
ClinicalTrials.gov Identifier: NCT00578695    
Other Study ID Numbers: CK-LX3401
First Posted: December 21, 2007    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: November 2010
Keywords provided by CardioKine Inc.:
Hyponatremia
Serum Sodium
Fluid Overload
 Heart Failure
Acute Heart Failure
Vasopressin Antagonist
Additional relevant MeSH terms:
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Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases