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Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia

Primary Purpose

Hyponatremia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
YM087
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, vasopressins, YM087

Eligibility Criteria

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

Inclusion Criteria:

  • Serum sodium levels 115 to < 130mEq/L
  • Euvolemic or Hypervolemic hyponatremia

Exclusion Criteria:

  • Clinical evidence of volume depletion or dehydration
  • Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency
  • Uncontrolled brady-or tachyarrhythmias requiring pacemaker placement or treatment

Sites / Locations

Outcomes

Primary Outcome Measures

The primary efficacy outcome will be change from baseline in serum sodium over the duration of treatment. The primary safety outcome will be safety parameters (e.g., adverse events, vital signs, EGG, laboratory measurements).

Secondary Outcome Measures

Full Information

First Posted
September 22, 2006
Last Updated
April 30, 2014
Sponsor
Cumberland Pharmaceuticals
Collaborators
Astellas Pharma US, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00380575
Brief Title
Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia
Official Title
A 4-Day, Double-Blind, Placebo-Controlled, Multicenter Study of IV 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
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cumberland Pharmaceuticals
Collaborators
Astellas Pharma US, Inc.

4. Oversight

5. Study Description

Brief Summary
This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients 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, vasopressins, YM087

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
84 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
YM087
Primary Outcome Measure Information:
Title
The primary efficacy outcome will be change from baseline in serum sodium over the duration of treatment. The primary safety outcome will be safety parameters (e.g., adverse events, vital signs, EGG, laboratory measurements).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Serum sodium levels 115 to < 130mEq/L Euvolemic or Hypervolemic hyponatremia Exclusion Criteria: Clinical evidence of volume depletion or dehydration Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency Uncontrolled brady-or tachyarrhythmias requiring pacemaker placement or treatment
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
Mobile
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Tuscon
State/Province
Arizona
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Santa Rosa
State/Province
California
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Plantation
State/Province
Florida
Country
United States
City
Springfield
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Worchester
State/Province
Massachusetts
Country
United States
City
Petoskey
State/Province
Michigan
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
Rolla
State/Province
Missouri
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
New York
State/Province
New York
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Sioux Falls
State/Province
South Dakota
Country
United States
City
Chattanooga
State/Province
Tennessee
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Salem
State/Province
Virginia
Country
United States
City
Huntington
State/Province
West Virginia
Country
United States
City
Madison
State/Province
Wisconsin
Country
United States
City
Drummondville
State/Province
Quebec
Country
Canada
City
Montreal 2 sites
State/Province
Quebec
Country
Canada
City
Ashkelon
Country
Israel
City
Beer Sheva
Country
Israel
City
Haifa 2 Sites
Country
Israel
City
Holon
Country
Israel
City
Jerusalem
Country
Israel
City
Rechovot
Country
Israel
City
Safed
Country
Israel
City
Tel Aviv
Country
Israel
City
Tel Hashomer
Country
Israel
City
Amanzimtoti
Country
South Africa
City
Bloemfontein
Country
South Africa
City
Buff
Country
South Africa
City
Durban
Country
South Africa
City
East London
Country
South Africa
City
Johannesburg
Country
South Africa
City
Lyttelton Manor
Country
South Africa
City
Port Elizabeth
Country
South Africa
City
Pretoria
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
17664863
Citation
Zeltser D, Rosansky S, van Rensburg H, Verbalis JG, Smith N; Conivaptan Study Group. Assessment of the efficacy and safety of intravenous conivaptan in euvolemic and hypervolemic hyponatremia. Am J Nephrol. 2007;27(5):447-57. doi: 10.1159/000106456. Epub 2007 Jul 26.
Results Reference
background
PubMed Identifier
18034777
Citation
Verbalis JG, Zeltser D, Smith N, Barve A, Andoh M. Assessment of the efficacy and safety of intravenous conivaptan in patients with euvolaemic hyponatraemia: subgroup analysis of a randomized, controlled study. Clin Endocrinol (Oxf). 2008 Jul;69(1):159-68. doi: 10.1111/j.1365-2265.2007.03149.x. Epub 2008 Jul 1.
Results Reference
background

Learn more about this trial

Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia

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