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

Cumberland Pharmaceuticals251 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

251

Conditions

Hyponatremia

Interventions

conivaptanDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (28)

Unnamed facility

Tuscon, Arizona, United States

Unnamed facility

Denver, Colorado, United States

Outcomes

Primary Outcomes

Baseline-adjusted change in AUC for serum sodium

Time frame: 96 Hours

Secondary Outcomes

Comparison of safety between patients in each study arm

Time frame: 96 Hours

Data from ClinicalTrials.gov

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