Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia
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
1 other identifier
interventional
84
4 countries
47
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2000
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 22, 2006
CompletedFirst Posted
Study publicly available on registry
September 26, 2006
CompletedMay 2, 2014
April 1, 2014
September 22, 2006
April 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Interventions
Eligibility Criteria
You may qualify if:
- Serum sodium levels 115 to \< 130mEq/L
- Euvolemic or Hypervolemic hyponatremia
You may not qualify if:
- Clinical evidence of volume depletion or dehydration
- Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency
- Uncontrolled brady-or tachyarrhythmias requiring pacemaker placement or treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cumberland Pharmaceuticalslead
- Astellas Pharma US, Inc.collaborator
Study Sites (47)
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tuscon, Arizona, United States
Unknown Facility
La Jolla, California, United States
Unknown Facility
Los Angeles, California, United States
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Santa Rosa, California, United States
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Miami, Florida, United States
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Plantation, Florida, United States
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Springfield, Illinois, United States
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Indianapolis, Indiana, United States
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Shreveport, Louisiana, United States
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Worchester, Massachusetts, United States
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Petoskey, Michigan, United States
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Minneapolis, Minnesota, United States
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Rolla, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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New York, New York, United States
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Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Columbia, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Chattanooga, Tennessee, United States
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Norfolk, Virginia, United States
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Salem, Virginia, United States
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Huntington, West Virginia, United States
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Madison, Wisconsin, United States
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Drummondville, Quebec, Canada
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Montreal 2 Sites, Quebec, Canada
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Ashkelon, Israel
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Beersheba, Israel
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Haifa 2 Sites, Israel
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Holon, Israel
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Jerusalem, Israel
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Rehovot, Israel
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Safed, Israel
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Tel Aviv, Israel
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Tel Litwinsky, Israel
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Bloemfontein, South Africa
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Buff, South Africa
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Durban, South Africa
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East London, South Africa
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eManzimtoti, South Africa
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Johannesburg, South Africa
Unknown Facility
Lyttelton Manor, South Africa
Unknown Facility
Port Elizabeth, South Africa
Unknown Facility
Pretoria, South Africa
Related Publications (2)
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.
PMID: 17664863BACKGROUNDVerbalis 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.
PMID: 18034777BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Art Wheeler, MD
Cumberland Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 22, 2006
First Posted
September 26, 2006
Study Start
August 1, 2000
Study Completion
February 1, 2003
Last Updated
May 2, 2014
Record last verified: 2014-04