REMODEL: The Purpose of This Study is to Determine if Eplerenone is Effective in Treatment of Mild to Moderate Heart Failure
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00082589
Collaborator
(none)
250
53
23
4.7
0.2
Study Details
Study Description
Brief Summary
The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double
Primary Purpose:
Treatment
Official 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
Study Start Date
:
Apr 1, 2004
Study Completion Date
:
Mar 1, 2006
Outcome Measures
Primary Outcome Measures
- Difference between eplerenone and placebo in change from baseline in LV end diastolic volume index (EDVi) determined by equilibrium-gated radionuclide ventriculography (RVG) []
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Castro Valley | California | United States | 94546 |
| 2 | Pfizer Investigational Site | San Diego | California | United States | 92103-8411 |
| 3 | Pfizer Investigational Site | Santa Rosa | California | United States | 95403 |
| 4 | Pfizer Investigational Site | Walnut Creek | California | United States | 94598-3084 |
| 5 | Pfizer Investigational Site | Denver | Colorado | United States | 80262 |
| 6 | Pfizer Investigational Site | New Haven | Connecticut | United States | 06510 |
| 7 | Pfizer Investigational Site | Fort Lauderdale | Florida | United States | 33308 |
| 8 | Pfizer Investigational Site | Jacksonville | Florida | United States | 32209 |
| 9 | Pfizer Investigational Site | Jacksonville | Florida | United States | 32216 |
| 10 | Pfizer Investigational Site | Atlanta | Georgia | United States | 30309-1721 |
| 11 | Pfizer Investigational Site | Augusta | Georgia | United States | 30901 |
| 12 | Pfizer Investigational Site | Covington | Georgia | United States | 30014 |
| 13 | Pfizer Investigational Site | Boise | Idaho | United States | 83704-0107 |
| 14 | Pfizer Investigational Site | Bloomington | Illinois | United States | 61701 |
| 15 | Pfizer Investigational Site | Normal | Illinois | United States | 61761 |
| 16 | Pfizer Investigational Site | Indianapolis | Indiana | United States | 46202 |
| 17 | Pfizer Investigational Site | Indianapolis | Indiana | United States | 46260 |
| 18 | Pfizer Investigational Site | Auburn | Maine | United States | 04210 |
| 19 | Pfizer Investigational Site | Ann Arbor | Michigan | United States | 48105 |
| 20 | Pfizer Investigational Site | Detroit | Michigan | United States | 48201 |
| 21 | Pfizer Investigational Site | Minneapolis | Minnesota | United States | 55415 |
| 22 | Pfizer Investigational Site | Minneapolis | Minnesota | United States | 55422 |
| 23 | Pfizer Investigational Site | Saint Louis | Missouri | United States | 63104 |
| 24 | Pfizer Investigational Site | Saint Louis | Missouri | United States | 63110-0250 |
| 25 | Pfizer Investigational Site | Saint Louis | Missouri | United States | 63110 |
| 26 | Pfizer Investigational Site | Saint Louis | Missouri | United States | 63117 |
| 27 | Pfizer Investigational Site | Lexington | Nebraska | United States | 68850 |
| 28 | Pfizer Investigational Site | Lincoln | Nebraska | United States | 68516 |
| 29 | Pfizer Investigational Site | McCook | Nebraska | United States | 69001 |
| 30 | Pfizer Investigational Site | Lebanon | New Hampshire | United States | 03756 |
| 31 | Pfizer Investigational Site | Albany | New York | United States | 12205 |
| 32 | Pfizer Investigational Site | Manhasset | New York | United States | 11030 |
| 33 | Pfizer Investigational Site | New York | New York | United States | 10032 |
| 34 | Pfizer Investigational Site | West Islip | New York | United States | 11795 |
| 35 | Pfizer Investigational Site | Mount Airy | North Carolina | United States | 27030 |
| 36 | Pfizer Investigational Site | Winston-Salem | North Carolina | United States | 27109 |
| 37 | Pfizer Investigational Site | Cincinnati | Ohio | United States | 45219 |
| 38 | Pfizer Investigational Site | Lorain | Ohio | United States | 44053 |
| 39 | Pfizer Investigational Site | Sandusky | Ohio | United States | 44870-3390 |
| 40 | Pfizer Investigational Site | Oklahoma City | Oklahoma | United States | 73120 |
| 41 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19104 |
| 42 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19107 |
| 43 | Pfizer Investigational Site | Sayre | Pennsylvania | United States | 18840 |
| 44 | Pfizer Investigational Site | Pawtucket | Rhode Island | United States | 02860 |
| 45 | Pfizer Investigational Site | Charleston | South Carolina | United States | 29401 |
| 46 | Pfizer Investigational Site | Germantown | Tennessee | United States | 38138 |
| 47 | Pfizer Investigational Site | Nashville | Tennessee | United States | 37212 |
| 48 | Pfizer Investigational Site | Beaumont | Texas | United States | 77630 |
| 49 | Pfizer Investigational Site | Beaumont | Texas | United States | 77702 |
| 50 | Pfizer Investigational Site | Houston | Texas | United States | 77030 |
| 51 | Pfizer Investigational Site | Galax | Virginia | United States | 24333 |
| 52 | Pfizer Investigational Site | Roanoke | Virginia | United States | 24014 |
| 53 | Pfizer Investigational Site | Madison | Wisconsin | United States | 53792 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00082589
Other Study ID Numbers:
- A6141078
First Posted:
May 14, 2004
Last Update Posted:
Dec 22, 2020
Last Verified:
Dec 1, 2020