Clinical Trial: Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia

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

Official Title: A 4-Day, Double-Blind, Placebo-Controlled, Multicenter Study of IV YM087 (CI-1025) to Assess Efficacy and Safety 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: The primary efficacy outcome will be change from baseline in serum sodium over the duration of treatment. The primary safety outcome will be safety parameters (e.g., adverse events, vital signs, EGG, laboratory measurements).

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Cumberland Pharmaceuticals

Dates:
Date Received: September 22, 2006
Date Started: August 2000
Date Completion:
Last Updated: April 30, 2014
Last Verified: April 2014