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NCT00492037 Clinical Trial

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

Hyponatremia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00492037
Other study ID # 087-CL-043
Secondary ID 1025-023
Status Completed
Phase Phase 3
First received June 25, 2007
Last updated April 30, 2014
Start date January 2000
Est. completion date February 2002

Study information
Verified date April 2014
Source Cumberland Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia

Recruitment information / eligibility
Status Completed
Enrollment 83
Est. completion date February 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• YM087 oral

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Cumberland Pharmaceuticals Parke-Davis

Countries where clinical trial is conducted

Belgium,  Finland,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in serum sodium from Baseline Safety of each dosing regimen Beginning through end of treatment
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