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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00492037
Recruitment Status : Completed
First Posted : June 27, 2007
Last Update Posted : May 2, 2014
Information provided by:
Cumberland Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Hyponatremia Drug: YM087 oral Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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 Start Date : January 2000
Actual Study Completion Date : February 2002

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in serum sodium from Baseline Safety of each dosing regimen [ Time Frame: Beginning through end of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00492037

Bruxelles, Belgium
Liege, Belgium
Tournai, Belgium
Jyväskylä, Finland
Turku, Finland
Garches, France
Limoges, France
Paris Cedex 10, France
Bad Nauheim, Germany
Berlin, Germany
Dresdan, Germany
Göttingen, Germany
Munchen, Germany
Ferrara, Italy
Pavia, Italy
Pisa, Italy
Verona, Italy
Delft, Netherlands
Groningen, Netherlands
Leiden, Netherlands
Nijmegen, Netherlands
Radomsko, Poland
Warsaw, Poland
Wroclaw, Poland
Barcelona, Spain
Cordoba, Spain
Madrid, Spain
United Kingdom
Cardiff, United Kingdom
Manchester, United Kingdom
Sponsors and Collaborators
Cumberland Pharmaceuticals
Study Director: Art Wheeler, MD Cumberland Pharmaceuticals Inc. Identifier: NCT00492037     History of Changes
Other Study ID Numbers: 087-CL-043
First Posted: June 27, 2007    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: April 2014

Keywords provided by Cumberland Pharmaceuticals:

Additional relevant MeSH terms:
Water-Electrolyte Imbalance
Metabolic Diseases
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs