Back to resultsStudy of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia
Primary Purpose
Hyponatremia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
YM087 oral
Sponsored by
About this trial
This is an interventional treatment trial for Hyponatremia focused on measuring hyponatremia, hypervolemic, euvolemic, conivaptan
Eligibility 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)
Sites / Locations
Outcomes
Primary Outcome Measures
Change in serum sodium from Baseline Safety of each dosing regimen
Secondary Outcome Measures
Full Information
NCT ID
NCT00492037
First Posted
June 25, 2007
Last Updated
April 30, 2014
Sponsor
Cumberland Pharmaceuticals
Collaborators
Parke-Davis
1. Study Identification
Unique Protocol Identification Number
NCT00492037
Brief Title
Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cumberland Pharmaceuticals
Collaborators
Parke-Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyponatremia
Keywords
hyponatremia, hypervolemic, euvolemic, conivaptan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
YM087 oral
Primary Outcome Measure Information:
Title
Change in serum sodium from Baseline Safety of each dosing regimen
Time Frame
Beginning through end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Art Wheeler, MD
Organizational Affiliation
Cumberland Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
City
Bruxelles
Country
Belgium
City
Liege
Country
Belgium
City
Tournai
Country
Belgium
City
Jyväskylä
Country
Finland
City
Turku
Country
Finland
City
Garches
Country
France
City
Limoges
Country
France
City
Paris Cedex 10
Country
France
City
Bad Nauheim
Country
Germany
City
Berlin
Country
Germany
City
Dresdan
Country
Germany
City
Göttingen
Country
Germany
City
Munchen
Country
Germany
City
Ferrara
Country
Italy
City
Pavia
Country
Italy
City
Pisa
Country
Italy
City
Verona
Country
Italy
City
Delft
Country
Netherlands
City
Groningen
Country
Netherlands
City
Leiden
Country
Netherlands
City
Nijmegen
Country
Netherlands
City
Radomsko
Country
Poland
City
Warsaw
Country
Poland
City
Wroclaw
Country
Poland
City
Barcelona
Country
Spain
City
Cordoba
Country
Spain
City
Madrid
Country
Spain
City
Cardiff
Country
United Kingdom
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia
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