Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia

April 30, 2014 updated by: Cumberland Pharmaceuticals

A 5-Day, Double-Blind, Placebo-Controlled Multicenter Study of Oral YM087 (CI-1025) to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia

Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

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

  • Belgium
      • Bruxelles, Belgium
      • Liege, Belgium
      • Tournai, Belgium
  • Finland
      • Jyväskylä, Finland
      • Turku, Finland
  • France
      • Garches, France
      • Limoges, France
      • Paris Cedex 10, France
  • Germany
      • Bad Nauheim, Germany
      • Berlin, Germany
      • Dresdan, Germany
      • Göttingen, Germany
      • Munchen, Germany
  • Italy
      • Ferrara, Italy
      • Pavia, Italy
      • Pisa, Italy
      • Verona, Italy
  • Netherlands
      • Delft, Netherlands
      • Groningen, Netherlands
      • Leiden, Netherlands
      • Nijmegen, Netherlands
  • Poland
      • Radomsko, Poland
      • Warsaw, Poland
      • Wroclaw, Poland
  • Spain
      • Barcelona, Spain
      • Cordoba, Spain
      • Madrid, Spain
  • United Kingdom
      • Cardiff, United Kingdom
      • Manchester, United Kingdom

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Serum Sodium 115 to <130mEq/L
  • Plasma Osmolarity <290 mOsmol/kg H2O

Exclusion Criteria:

  • Significant renal insufficiency
  • Serum sodium increase of ≥8 mEq/L over the baseline day ( Hours 0 to 12)

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
Time Frame
Change in serum sodium from Baseline Safety of each dosing regimen
Time Frame: Beginning through end of treatment
Beginning through end of treatment

Collaborators and Investigators

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

Sponsor

Cumberland Pharmaceuticals

Collaborators

Parke-Davis

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

January 1, 2000

Study Completion (Actual)

February 1, 2002

Study Registration Dates

First Submitted

June 25, 2007

First Submitted That Met QC Criteria

June 25, 2007

First Posted (Estimate)

June 27, 2007

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-043
  • 1025-023

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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