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:

MedlinePlus related topics: Heart Failure

Drug Information available for: Lixivaptan

U.S. FDA Resources

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