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
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
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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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)
Both
18 Years to 85 Years
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
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