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Study 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
Cumberland Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyponatremia focused on measuring hyponatremia, hypervolemic, euvolemic, conivaptan

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 25, 2007
Last Updated
April 30, 2014
Sponsor
Cumberland Pharmaceuticals
Collaborators
Parke-Davis
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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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