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

Phase 3 Withdrawn 300 enrolled CardioKine Inc. Biogen · collab Cardiokine Biopharma, LLC · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

To demonstrate that after 12 weeks of open-label lixivaptan treatment, serum sodium is maintained in hyponatremic patients continuing to receive lixivaptan compared to placebo during the 4 week double blind treatment period.

Timeline

Start: 2009-07
Primary completion: 2010-08
Completion: 2010-12

Outcome

Outcome not reported

Stopped: “Created Extension study - This study was no longer feasible”

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lixivaptan	Small molecule	25 mg	Oral
Subject	Lixivaptan	Small molecule	50 mg	Oral

Indications

No indication recorded.