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

June 25, 2007
April 30, 2014
January 2000
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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
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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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hyponatremia
Drug: YM087 oral
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
February 2002
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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)
Both
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
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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