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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
June 25, 2007
June 27, 2007
May 2, 2014
January 2000
Not Provided
Change in serum sodium from Baseline Safety of each dosing regimen [ Time Frame: Beginning through end of treatment ]
Same as current
Complete list of historical versions of study NCT00492037 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Hyponatremia
Drug: YM087 oral
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
February 2002
Not Provided

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)
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Finland,   France,   Germany,   Italy,   Netherlands,   Poland,   Spain,   United Kingdom
 
 
NCT00492037
087-CL-043
1025-023
No
Not Provided
Not Provided
Not Provided
Cumberland Pharmaceuticals
Parke-Davis
Study Director: Art Wheeler, MD Cumberland Pharmaceuticals Inc.
Cumberland Pharmaceuticals
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP