A Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients
NCT ID: NCT00592475
Last Updated: 2014-05-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2007-12-31
2008-11-30
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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Regimen 1 Conivaptan 12.5 mg
Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
conivaptan
IV
Regimen 2 Conivaptan 25 mg
Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
conivaptan
IV
Regimen 3 Placebo
Placebo continuous intravenous infusion over 6.5 hours
Placebo
IV
Interventions
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conivaptan
IV
Placebo
IV
Eligibility Criteria
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Inclusion Criteria
* Subject is euvolemic or hypervolemic (edematous) secondary to cirrhosis
* Subject has clinical evidence of portal hypertension by the presence of esophageal varices, ascites or both
Exclusion Criteria
* Subject has a history of bleeding from esophageal varices within three months before the start of the study
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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Barcelona, , Spain
Countries
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Related Links
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(Link to Prescribing Information)
Other Identifiers
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2007-001661-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
087-CL-089
Identifier Type: -
Identifier Source: org_study_id
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