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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00492037
First Posted: June 27, 2007
Last Update Posted: May 2, 2014
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.
Collaborator:
Parke-Davis
Information provided by:
Cumberland Pharmaceuticals
  Purpose
Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia

Condition Intervention Phase
Hyponatremia Drug: YM087 oral Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Cumberland Pharmaceuticals:

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

Enrollment: 83
Study Start Date: January 2000
Study Completion Date: February 2002
  Eligibility

Information from the National Library of Medicine

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

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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00492037


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
Sponsors and Collaborators
Cumberland Pharmaceuticals
Parke-Davis
Investigators
Study Director: Art Wheeler, MD Cumberland Pharmaceuticals Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00492037     History of Changes
Other Study ID Numbers: 087-CL-043
1025-023
First Submitted: June 25, 2007
First Posted: June 27, 2007
Last Update Posted: May 2, 2014
Last Verified: April 2014

Keywords provided by Cumberland Pharmaceuticals:
hyponatremia
hypervolemic
euvolemic
conivaptan

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