An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia
NCT ID: NCT00379847
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
251 participants
INTERVENTIONAL
2004-02-29
2005-06-30
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
NONE
Study Groups
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1
Lower dose
conivaptan
IV
2
Higher dose
conivaptan
IV
Interventions
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conivaptan
IV
Other Intervention Names
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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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Cumberland Pharmaceuticals
INDUSTRY
Responsible Party
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Astellas Pharma US, Inc.
Principal Investigators
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Art Wheeler, MD
Role: STUDY_DIRECTOR
Cumberland Pharmaceuticals, Inc.
Locations
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Tuscon, Arizona, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Augusta, Georgia, United States
Petoskey, Michigan, United States
Cincinnati, Ohio, United States
Columbia, South Carolina, United States
Afula, , Israel
Ashkelon, , Israel
Hadera, , Israel
2 Sites
Haifa, , Israel
Holon, , Israel
2 Sites
Jerusalem, , Israel
Nahariya, , Israel
Rehovot, , Israel
2 Sites
Safed, , Israel
Tel Aviv, , Israel
Ẕerifin, , Israel
Amanzimototi, , South Africa
Bellville, , South Africa
Bloemfontein, , South Africa
2 Sites
Durban, , South Africa
4 Sites
Johannesburg, , South Africa
Krugersdorp, , South Africa
Lyttelton, , South Africa
Pretoria, , South Africa
Somerset West, , South Africa
Soweto, , South Africa
Countries
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Other Identifiers
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087-CL-080
Identifier Type: -
Identifier Source: org_study_id
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