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

Cumberland Pharmaceuticals84 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

DOUBLE

Enrollment

Conditions

Hyponatremia

Interventions

YM087DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (47)

Outcomes

Primary Outcomes

The primary efficacy outcome will be change from baseline in serum sodium over the duration of treatment. The primary safety outcome will be safety parameters (e.g., adverse events, vital signs, EGG, laboratory measurements).

Data from ClinicalTrials.gov

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Tuscon, Arizona, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Santa Rosa, California, United States

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Miami, Florida, United States

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Plantation, Florida, United States

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Springfield, Illinois, United States

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Indianapolis, Indiana, United States

...and 37 more locations