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

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.

Completed

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Key information

Conditions

Hyponatremia Diabetes Insipidus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pituitary Diseases Urogenital Diseases Urologic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Drummondville, Quebec, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YM087

Drug

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).

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Collaborators

Astellas Pharma US, Inc.

Registry information

Official study title

A 4-Day, Double-Blind, Placebo-Controlled, Multicenter Study of IV YM087 (CI-1025) to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia

Important dates

Study start: 2000
Study completion: 2003
First posted: Sep 26, 2006
Registry last updated: May 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed