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| ID | Type | Description | Link |
|---|---|---|---|
| SR121463B |
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This is a randomized, double-blind, placebo-controlled, parallel-group forced up-titration study. Randomization will be stratified according to the patient's baseline serum sodium concentration (137-144 and <137 mmol/L). The dose of study drug will be increased to the next level on Day 15, and the total duration of the double-blind treatment period is 120 days.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vasopressin V2 Receptor Antagonist | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical status at day 120. |
| Measure | Description | Time Frame |
|---|---|---|
| NYHA functional class, left ventricular ejection fraction, global assessment,serum sodium concentration. |
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Emory University |
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| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
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| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242-1081 | United States |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | United States |
| Brian LGH Heart Institute | Lincoln | Nebraska | 68510 | United States |
| The Lindner Clinical Trial Center | Cincinnati | Ohio | 45219 | United States |
| MUSC/Division Cardiology | Charleston | South Carolina | 29425 | United States |
| Sanofi-aventis Administrative Office | Laval | Canada |
| Sanofi-aventis Administrative Office | Guildford Surrey | United Kingdom |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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