Clinical Trial: An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A 4-day, Open-Label, Multicenter Phase 3b Study of IV YM087 in Patients With Euvolemic or Hypervolemic Hyponatremia
Brief Summary: This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients with euvolemic or hypervolemic hyponatremia.
Detailed Summary:
Sponsor: Cumberland Pharmaceuticals
Current Primary Outcome: Baseline-adjusted change in AUC for serum sodium [ Time Frame: 96 Hours ]
Original Primary Outcome: The primary efficacy outcome will be baseline-adjusted change in AUC for serum sodium over the 96-hour infusion. The primary safety outcome will be to compare the safety in patients treated with 20mg/day to the safety in patients treated with 40mg/day
Current Secondary Outcome: Comparison of safety between patients in each study arm [ Time Frame: 96 Hours ]
Original Secondary Outcome:
Information By: Cumberland Pharmaceuticals
Dates:
Date Received: September 21, 2006
Date Started: February 2004
Date Completion:
Last Updated: April 30, 2014
Last Verified: April 2014