THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
- Registration Number
- NCT00578695
- Lead Sponsor
- CardioKine Inc.
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 652
- Male and female patients 18 years of age or older with hyponatremia and hospitalized for congestive heart failure.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Active lixivaptan Lixivaptan
- Primary Outcome Measures
Name Time Method 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. 60 days
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (24)
Research Site 1
🇪🇸Vigo, Spain
Research Site
🇨🇭Geneva, Switzerland
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Northern Michigan Hospital
🇺🇸Petoskey, Michigan, United States
Siant Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Research Site 2
🇵🇱Krakow, Poland
Research Site1
🇺🇸Sayre, Pennsylvania, United States
hospital Interzonal General de Agudos, "Eva Peron" (HIGA)
🇦🇷San Martin, Buenos Aires, Argentina
Hospital Militar Central H Gral. 601 "Cirujano Mayor Dr. Cosme Argerich"
🇦🇷Buenos Aires, Argentina
Hospital de Clinicas "Jose de San Martin"
🇦🇷Buenos Aires, Argentina
Scroll for more (14 remaining)Research Site 1🇪🇸Vigo, Spain