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

This study has been completed.
Sponsor:
Collaborator:
Parke-Davis
Information provided by:
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00492037
First received: June 25, 2007
Last updated: April 30, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00492037     History of Changes
Other Study ID Numbers: 087-CL-043, 1025-023
Study First Received: June 25, 2007
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cumberland Pharmaceuticals:
hyponatremia
hypervolemic
euvolemic
conivaptan

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on July 24, 2014