Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia
NCT ID: NCT00380575
Last Updated: 2014-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
84 participants
INTERVENTIONAL
2000-08-31
2003-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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YM087
Eligibility Criteria
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Inclusion Criteria
* Euvolemic or Hypervolemic hyponatremia
Exclusion Criteria
* Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency
* Uncontrolled brady-or tachyarrhythmias requiring pacemaker placement or treatment
18 Years
ALL
No
Sponsors
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Astellas Pharma US, Inc.
INDUSTRY
Cumberland Pharmaceuticals
INDUSTRY
Principal Investigators
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Art Wheeler, MD
Role: STUDY_DIRECTOR
Cumberland Pharmaceuticals, Inc.
Locations
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Mobile, Alabama, United States
Phoenix, Arizona, United States
Tuscon, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Santa Rosa, California, United States
Miami, Florida, United States
Plantation, Florida, United States
Springfield, Illinois, United States
Indianapolis, Indiana, United States
Shreveport, Louisiana, United States
Worchester, Massachusetts, United States
Petoskey, Michigan, United States
Minneapolis, Minnesota, United States
Rolla, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
New York, New York, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Columbia, South Carolina, United States
Sioux Falls, South Dakota, United States
Chattanooga, Tennessee, United States
Norfolk, Virginia, United States
Salem, Virginia, United States
Huntington, West Virginia, United States
Madison, Wisconsin, United States
Drummondville, Quebec, Canada
Montreal 2 Sites, Quebec, Canada
Ashkelon, , Israel
Beersheba, , Israel
Haifa 2 Sites, , Israel
Holon, , Israel
Jerusalem, , Israel
Rehovot, , Israel
Safed, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
Bloemfontein, , South Africa
Buff, , South Africa
Durban, , South Africa
East London, , South Africa
eManzimtoti, , South Africa
Johannesburg, , South Africa
Lyttelton Manor, , South Africa
Port Elizabeth, , South Africa
Pretoria, , South Africa
Countries
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References
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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.
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.
Other Identifiers
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087-CL-027
Identifier Type: -
Identifier Source: org_study_id
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