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This is a randomized, double-blind, placebo-controlled, dose ranging pilot study to examine the effects of conivaptan in patients with acute decompensated heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental | Low dose |
|
| 3 | Experimental | Middle dose |
|
| 4 | Experimental | High dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conivaptan | Drug | IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in respiratory Visual analog Scale (VAS) | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in global VAS | 48 hours | |
| Total urine output vs. baseline | 72 hours |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Art Wheeler, MD | Cumberland Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Heart Center, P.C. | Huntsville | Alabama | 35801 | United States | ||
| LA County/USC Medical Center |
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| placebo | Drug | IV |
|
| Los Angeles |
| California |
| 90033 |
| United States |
| San Joaquin Cardiology | Manteca | California | 95337 | United States |
| Apex Research Institute | Santa Ana | California | 92705 | United States |
| The Greater Fort Lauderdale Heart Group Research | Fort Lauderdale | Florida | 33308 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| U. Miami, Jackson Mem'l Medical Center | Miami | Florida | 33136 | United States |
| Discovery Medical Research Group | Ocala | Florida | 34478 | United States |
| Rush-Presbyterian St. Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| Louisiana State University Medical Center School of Medicine | New Orleans | Louisiana | 70112 | United States |
| New Orleans Center for Clinical Research | New Orleans | Louisiana | 70119 | United States |
| Cardiac Centers of Louisiana, LLC | Shreveport | Louisiana | 71103 | United States |
| University of Maryland Hospital | Baltimore | Maryland | 20201 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| New York Presbyterian Hosp, Milstein Hosp. | New York | New York | 10032 | United States |
| University of Cincinnati, College of Medicine, Div. of Cardiology | Cincinnati | Ohio | 45267 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University Medical Center, Heart and Lung Research Institute | Columbus | Ohio | 43210 | United States |
| Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Baptist Clinical Research | Memphis | Tennessee | 38120 | United States |
| Cardiovascular Research Institute of Dallas | Dallas | Texas | 75231 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| ID | Term |
|---|---|
| C106389 | conivaptan |
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