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An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia

Primary Purpose

Hyponatremia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
conivaptan
Sponsored by
Cumberland Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyponatremia focused on measuring hyponatremia, hypervolemic, euvolemic, treatment outcomes, YM087

Eligibility Criteria

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

Inclusion Criteria:

  • Serum sodium levels less than or equal 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

  • 2 Sites
  • 2 Sites
  • 2 Sites
  • 2 Sites
  • 4 Sites

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Lower dose

Higher dose

Outcomes

Primary Outcome Measures

Baseline-adjusted change in AUC for serum sodium

Secondary Outcome Measures

Comparison of safety between patients in each study arm

Full Information

First Posted
September 21, 2006
Last Updated
April 30, 2014
Sponsor
Cumberland Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00379847
Brief Title
An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia
Official Title
A 4-day, Open-Label, Multicenter Phase 3b Study of IV YM087 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
February 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cumberland Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

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, treatment outcomes, YM087

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Lower dose
Arm Title
2
Arm Type
Experimental
Arm Description
Higher dose
Intervention Type
Drug
Intervention Name(s)
conivaptan
Other Intervention Name(s)
Vaprisol, YM087
Intervention Description
IV
Primary Outcome Measure Information:
Title
Baseline-adjusted change in AUC for serum sodium
Time Frame
96 Hours
Secondary Outcome Measure Information:
Title
Comparison of safety between patients in each study arm
Time Frame
96 Hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Serum sodium levels less than or equal 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
Tuscon
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49700
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29209
Country
United States
City
Afula
Country
Israel
City
Ashkelon
Country
Israel
City
Hadera
Country
Israel
Facility Name
2 Sites
City
Haifa
Country
Israel
City
Holon
Country
Israel
Facility Name
2 Sites
City
Jerusalem
Country
Israel
City
Nahariya
Country
Israel
City
Rechovot
Country
Israel
Facility Name
2 Sites
City
Safed
Country
Israel
City
Tel-Aviv
Country
Israel
City
Zerifin
Country
Israel
City
Amanzimototi
Country
South Africa
City
Bellville
Country
South Africa
City
Bloemfontein
Country
South Africa
Facility Name
2 Sites
City
Durban
Country
South Africa
Facility Name
4 Sites
City
Johannesburg
Country
South Africa
City
Krugersdorp
Country
South Africa
City
Lyttelton
Country
South Africa
City
Pretoria
Country
South Africa
City
Somerset West
Country
South Africa
City
Soweto
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia

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