Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia

• Status: Completed
• Trial end date: 2002-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia

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

Details

• Lead Sponsor: Cumberland Pharmaceuticals
• Collaborator: Parke-Davis
• Treatments: Conivaptan

Criteria

Inclusion Criteria:

• Serum Sodium 115 to <130mEq/L

• Plasma Osmolarity <290 mOsmol/kg H2O

Exclusion Criteria:

• Significant renal insufficiency

• Serum sodium increase of ≥8 mEq/L over the baseline day ( Hours 0 to 12)