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

Overview

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.

Full Title of Study: “A 4-day, Open-Label, Multicenter Phase 3b Study of IV YM087 in Patients With Euvolemic or Hypervolemic Hyponatremia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2005

Interventions

  • Drug: conivaptan
    • IV

Arms, Groups and Cohorts

  • Experimental: 1
    • Lower dose
  • Experimental: 2
    • Higher dose

Clinical Trial Outcome Measures

Primary Measures

  • Baseline-adjusted change in AUC for serum sodium
    • Time Frame: 96 Hours

Secondary Measures

  • Comparison of safety between patients in each study arm
    • Time Frame: 96 Hours

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cumberland Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc.
  • Overall Official(s)
    • Art Wheeler, MD, Study Director, Cumberland Pharmaceuticals, Inc.

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