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

April 30, 2014 updated by: Cumberland Pharmaceuticals

A 4-day, Open-Label, Multicenter Phase 3b Study of IV YM087 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 (Actual)

251

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

  • Israel
      • Afula, Israel
      • Ashkelon, Israel
      • Hadera, Israel
      • Haifa, Israel
        • 2 Sites
      • Holon, Israel
      • Jerusalem, Israel
        • 2 Sites
      • Nahariya, Israel
      • Rechovot, Israel
      • Safed, Israel
        • 2 Sites
      • Tel-Aviv, Israel
      • Zerifin, Israel
  • South Africa
      • Amanzimototi, South Africa
      • Bellville, South Africa
      • Bloemfontein, South Africa
      • Durban, South Africa
        • 2 Sites
      • Johannesburg, South Africa
        • 4 Sites
      • Krugersdorp, South Africa
      • Lyttelton, South Africa
      • Pretoria, South Africa
      • Somerset West, South Africa
      • Soweto, South Africa
  • United States
    • Arizona
      • Tuscon, Arizona, United States, 85723
    • Colorado
      • Denver, Colorado, United States, 80262
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
    • Georgia
      • Augusta, Georgia, United States, 30901
    • Michigan
      • Petoskey, Michigan, United States, 49700
    • Ohio
      • Cincinnati, Ohio, United States, 45219
    • South Carolina
      • Columbia, South Carolina, United States, 29209

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 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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Lower dose
Drug: conivaptan
IV
Other Names:
  • YM087
  • Vaprisol
Experimental: 2
Higher dose
Drug: conivaptan
IV
Other Names:
  • YM087
  • Vaprisol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Cumberland Pharmaceuticals

Investigators

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

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

February 1, 2004

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

September 21, 2006

First Submitted That Met QC Criteria

September 21, 2006

First Posted (Estimate)

September 25, 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-080

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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