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This Phase 2, randomized, placebo-controlled, multicenter outpatient study is designed to test the safety and tolerability of AC2592 as well as examine the effect of AC2592 on oxygen consumption during maximal tolerated exercise in adult subjects with chronic congestive heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC2592 | Drug | continuous subcutaneous infusion (via pump), dose based on subject body weight |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To examine the safety and tolerability of AC2592 administered by continuous subcutaneous infusion in subjects with chronic congestive heart failure. | 6 weeks | |
| To assess the effect of AC2592 administered by continuous subcutaneous infusion on oxygen consumption during maximal tolerated exercise in adult subjects with chronic congestive heart failure. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of AC2592 administered by continuous subcutaneous infusion on pharmacokinetics, pharmacodynamics, and clinical outcomes in adult subjects with chronic congestive heart failure. | 6 weeks |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Porter, MD | Amylin Pharmaceuticals, LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beverly Hills | California | United States | |||
| Research Site |
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| placebo |
| Drug |
continuous subcutaneous infusion (via pump), dose based on subject body weight |
|
| Mission Viejo |
| California |
| United States |
| Research Site | New Haven | Connecticut | United States |
| Research Site | Washington D.C. | District of Columbia | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Tampa | Florida | United States |
| Research Site | Peoria | Illinois | United States |
| Research Site | Springfield | Illinois | United States |
| Research Site | Winfield | Illinois | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Baton Rouge | Louisiana | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Auburn | Maine | United States |
| Research Site | Boston | Massachusetts | United States |
| Research Site | Detroit | Michigan | United States |
| Research Site | Lincoln | Nebraska | United States |
| Research Site | Chapel Hill | North Carolina | United States |
| Research Site | Durham | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Columbus | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Medford | Oregon | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Knoxville | Tennessee | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Houston | Texas | United States |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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