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

• Status: Completed
• Trial end date: 2003-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cumberland Pharmaceuticals
• Collaborator: Astellas Pharma US, Inc.
• Treatments: Conivaptan

Criteria

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