An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia

Phase 3

Completed

• Conditions: Hyponatremia
• Interventions: Drug: conivaptan

• Registration Number: NCT00379847
• 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: 2004-02
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2006-09-21
• Study First Submitted QC: 2006-09-21
• Study First Posted: 2006-09-25
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-30
• Last Update Posted: 2014-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

• Serum sodium levels less than or equal 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

Arm && Interventions

Group	Intervention	Description
1	conivaptan	Lower dose
2	conivaptan	Higher dose

Primary Outcome Measures

Name	Time	Method
Baseline-adjusted change in AUC for serum sodium	96 Hours

Secondary Outcome Measures

Name	Time	Method
Comparison of safety between patients in each study arm	96 Hours

Trial Locations

Locations (2)

2 Sites; 🇿🇦 Durban, South Africa

4 Sites; 🇿🇦 Johannesburg, South Africa