Clinical Trial: THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: CardioKine Inc.

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: CardioKine Inc.

Dates:
Date Received: December 19, 2007
Date Started: January 2007
Date Completion:
Last Updated: June 20, 2011
Last Verified: November 2010