Heart Failure, Congestive Clinical Trial
— REMODELOfficial title:
A Randomized, Double-Blind, Multi-Center,Study Evaluating the Effects of Eplerenone Versus Placebo on Ventricular Remodeling in Patient's With Left Ventricular Systolic Dysfunction (EF Less Than or Equal to 35%) and Mild to Moderate Heart Failure
| NCT number | NCT00082589 |
| Other study ID # | A6141078 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | April 2004 |
| Est. completion date | March 2006 |
| Verified date | December 2020 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure
| Status | Completed |
| Enrollment | 250 |
| Est. completion date | March 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility | Inclusion Criteria: - Current symptoms consistent with mild to moderate heart failure (NYHA functional class II and III) - LVEF (left ventricular ejection fraction) of <35% by equilibrium-gated RVG at screening - Therapy with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) and beta-blocker (BB) (unless documented intolerance) for at least 3 months duration and at dose that has not been adjusted within the previous 4 weeks Exclusion Criteria: - Current decompensated heart failure or heart failure hospitalization or severe heart failure (NYHA functional class IV) within 6 months of screening - Use of eplerenone or spironolactone within 30 days of randomization or for more than 7 days within the previous 6 months |
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Albany | New York |
| United States | Pfizer Investigational Site | Ann Arbor | Michigan |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Auburn | Maine |
| United States | Pfizer Investigational Site | Augusta | Georgia |
| United States | Pfizer Investigational Site | Beaumont | Texas |
| United States | Pfizer Investigational Site | Beaumont | Texas |
| United States | Pfizer Investigational Site | Bloomington | Illinois |
| United States | Pfizer Investigational Site | Boise | Idaho |
| United States | Pfizer Investigational Site | Castro Valley | California |
| United States | Pfizer Investigational Site | Charleston | South Carolina |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Covington | Georgia |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Detroit | Michigan |
| United States | Pfizer Investigational Site | Fort Lauderdale | Florida |
| United States | Pfizer Investigational Site | Galax | Virginia |
| United States | Pfizer Investigational Site | Germantown | Tennessee |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Indianapolis | Indiana |
| United States | Pfizer Investigational Site | Indianapolis | Indiana |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | Lebanon | New Hampshire |
| United States | Pfizer Investigational Site | Lexington | Nebraska |
| United States | Pfizer Investigational Site | Lincoln | Nebraska |
| United States | Pfizer Investigational Site | Lorain | Ohio |
| United States | Pfizer Investigational Site | Madison | Wisconsin |
| United States | Pfizer Investigational Site | Manhasset | New York |
| United States | Pfizer Investigational Site | McCook | Nebraska |
| United States | Pfizer Investigational Site | Minneapolis | Minnesota |
| United States | Pfizer Investigational Site | Minneapolis | Minnesota |
| United States | Pfizer Investigational Site | Mount Airy | North Carolina |
| United States | Pfizer Investigational Site | Nashville | Tennessee |
| United States | Pfizer Investigational Site | New Haven | Connecticut |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | Normal | Illinois |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Pawtucket | Rhode Island |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Roanoke | Virginia |
| United States | Pfizer Investigational Site | Saint Louis | Missouri |
| United States | Pfizer Investigational Site | Saint Louis | Missouri |
| United States | Pfizer Investigational Site | Saint Louis | Missouri |
| United States | Pfizer Investigational Site | Saint Louis | Missouri |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | Sandusky | Ohio |
| United States | Pfizer Investigational Site | Santa Rosa | California |
| United States | Pfizer Investigational Site | Sayre | Pennsylvania |
| United States | Pfizer Investigational Site | Walnut Creek | California |
| United States | Pfizer Investigational Site | West Islip | New York |
| United States | Pfizer Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Difference between eplerenone and placebo in change from baseline in LV end diastolic volume index (EDVi) determined by equilibrium-gated radionuclide ventriculography (RVG) |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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