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

April 30, 2014 updated by: Cumberland Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

84

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Drummondville, Quebec, Canada
      • Montreal 2 sites, Quebec, Canada
  • Israel
      • Ashkelon, Israel
      • Beer Sheva, Israel
      • Haifa 2 Sites, Israel
      • Holon, Israel
      • Jerusalem, Israel
      • Rechovot, Israel
      • Safed, Israel
      • Tel Aviv, Israel
      • Tel Hashomer, Israel
  • South Africa
      • Amanzimtoti, South Africa
      • Bloemfontein, South Africa
      • Buff, South Africa
      • Durban, South Africa
      • East London, South Africa
      • Johannesburg, South Africa
      • Lyttelton Manor, South Africa
      • Port Elizabeth, South Africa
      • Pretoria, South Africa
  • United States
    • Alabama
      • Mobile, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tuscon, Arizona, United States
    • California
      • La Jolla, California, United States
      • Los Angeles, California, United States
      • Santa Rosa, California, United States
    • Florida
      • Miami, Florida, United States
      • Plantation, Florida, United States
    • Illinois
      • Springfield, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Massachusetts
      • Worchester, Massachusetts, United States
    • Michigan
      • Petoskey, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Missouri
      • Rolla, Missouri, United States
      • St. Louis, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New York
      • New York, New York, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • South Carolina
      • Columbia, South Carolina, United States
    • South Dakota
      • Sioux Falls, South Dakota, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Salem, Virginia, United States
    • West Virginia
      • Huntington, West Virginia, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cumberland Pharmaceuticals

Collaborators

Astellas Pharma US, Inc.

Investigators

  • Study Director: Art Wheeler, MD, Cumberland Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Study Completion (Actual)

February 1, 2003

Study Registration Dates

First Submitted

September 22, 2006

First Submitted That Met QC Criteria

September 22, 2006

First Posted (Estimate)

September 26, 2006

Study Record Updates

Last Update Posted (Estimate)

May 2, 2014

Last Update Submitted That Met QC Criteria

April 30, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 087-CL-027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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