A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
NCT ID: NCT00435591
Last Updated: 2014-05-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
121 participants
INTERVENTIONAL
2007-01-31
2008-09-30
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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Dose Regimen 1
Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
Conivaptan
ampoule or premix bag
placebo
ampoule or premix bag
Dose Regimen 2
Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
Conivaptan
ampoule or premix bag
Dose Regimen 3
Placebo loading dose + 20mg/day continuous infusion conivaptan per premix bag
Conivaptan
ampoule or premix bag
placebo
ampoule or premix bag
Dose Regimen 4
Conivaptan loading dose (20mg) + 20mg/day continuous infusion conivaptan per premix bag
Conivaptan
ampoule or premix bag
Interventions
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Conivaptan
ampoule or premix bag
placebo
ampoule or premix bag
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is euvolemic or hypervolemic
Exclusion Criteria
* Uncontrolled brady- or tachyarrhythmias requiring emergent pacemaker placement or treatment
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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Charleston, South Carolina, United States
Bangalore, , India
Bangalore, , India
Bhopal, , India
Hyderabaad, , India
Karnāl, , India
Afula, , Israel
Ashkelon, , Israel
Haifa, , Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Jerusalem, , Israel
Rehovot, , Israel
Safed, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
Ẕerifin, , Israel
Countries
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References
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Kalra S, Efrati S, Arthur JM, Oliven A, Velez JC, McNutt BE, Klasen S, Abeyratne A. Effect of loading dose and formulation on safety and efficacy of conivaptan in treatment of euvolemic and hypervolemic hyponatremia. Am J Health Syst Pharm. 2011 Apr 1;68(7):590-8. doi: 10.2146/ajhp100243.
Related Links
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Link to Prescribing Information
Other Identifiers
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087-CL-084
Identifier Type: -
Identifier Source: org_study_id
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