International, Multicenter, Open-Label and Randomized Withdrawal Study of Oral Lixivaptan in Heart Failure Patients With Chronic Hyponatremia

PHASE3WithdrawnINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

August 31, 2010

Study Completion Date

December 31, 2010

Conditions
Hypervolemic Hyponatremia
Interventions
DRUG

Lixivaptan

Capsules containing 25, or 50 mg doses of oral lixivaptan to be administered BID or QD Lixivaptan will be administered for 12 weeks in the Open-Label Period which will be followed by a 4 week Randomized, Placebo-Controlled period.

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Cardiokine Biopharma, LLC

INDUSTRY

collaborator

Biogen

INDUSTRY

lead

CardioKine Inc.

INDUSTRY