Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
NCT ID: NCT00478192
Last Updated: 2014-05-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
50 participants
INTERVENTIONAL
2007-04-30
2008-08-31
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
Study Groups
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Regimen 1 Conivaptan QD
20 mg conivaptan once a day
Conivaptan
premix bag
Regimen 2 Conivaptan BID
20 mg conivaptan two times a day
Conivaptan
premix bag
Regimen 3 Placebo
Placebo
premix bag
Interventions
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Conivaptan
premix bag
Placebo
premix bag
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Serum sodium between 115 and 130mEq/L at baseline
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Cumberland Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Art Wheeler, MD
Role: STUDY_DIRECTOR
Cumberland Pharmaceuticals, Inc.
Locations
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Huntsville, Alabama, United States
Tucson, Arizona, United States
Los Angeles, California, United States
Denver, Colorado, United States
Jacksonville, Florida, United States
Port Charlotte, Florida, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Hazard, Kentucky, United States
Detroit, Michigan, United States
Omaha, Nebraska, United States
The Bronx, New York, United States
Cincinnati, Ohio, United States
Fairfield, Ohio, United States
Toledo, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Orangeburg, South Carolina, United States
Coimbatore, , India
Indore, , India
Jaipur, , India
Karnāl, , India
Visakhapatnam, , India
Countries
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References
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Koren MJ, Hamad A, Klasen S, Abeyratne A, McNutt BE, Kalra S. Efficacy and safety of 30-minute infusions of conivaptan in euvolemic and hypervolemic hyponatremia. Am J Health Syst Pharm. 2011 May 1;68(9):818-27. doi: 10.2146/ajhp100260.
Related Links
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Link to Prescribing Information
Other Identifiers
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087-CL-088
Identifier Type: -
Identifier Source: org_study_id
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