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

Phase 3

Completed

• Conditions: Hyponatremia

• Registration Number: NCT00380575
• Lead Sponsor: Cumberland Pharmaceuticals

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 Description

Not available

Study Timeline

• Study Start: 2000-08
• Study Completion: 2003-02
• Study First Submitted: 2006-09-22
• Study First Submitted QC: 2006-09-22
• Study First Posted: 2006-09-26
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-30
• Last Update Posted: 2014-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Serum sodium levels 115 to < 130mEq/L
• Euvolemic or Hypervolemic hyponatremia

Exclusion Criteria

• Clinical evidence of volume depletion or dehydration
• Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency
• Uncontrolled brady-or tachyarrhythmias requiring pacemaker placement or treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).