Heart Failure, CongestivePhase 4REMODELNCT00082589
The Purpose of This Study is to Determine if Eplerenone is Effective in Treatment of Mild to Moderate Heart Failure
A Phase 4 study testing Eplerenone in people with Heart Failure, Congestive, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 53 sites in United States.
Trial summary
The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- Eplerenone
- How many people
- 250 participants
- Where
- 53 sitesUnited States
- Study dates
- Apr 2004to Mar 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
Pfizer Investigational Site
Albany, New York, 12205
Pfizer Investigational Site
Ann Arbor, Michigan, 48105
Pfizer Investigational Site
Atlanta, Georgia, 30309-1721
Pfizer Investigational Site
Auburn, Maine, 04210
Pfizer Investigational Site
Augusta, Georgia, 30901
Pfizer Investigational Site
Beaumont, Texas, 77630
Pfizer Investigational Site
Beaumont, Texas, 77702
Pfizer Investigational Site
Bloomington, Illinois, 61701
Pfizer Investigational Site
Boise, Idaho, 83704-0107
Pfizer Investigational Site
Castro Valley, California, 94546
Pfizer Investigational Site
Charleston, South Carolina, 29401
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Covington, Georgia, 30014
Pfizer Investigational Site
Denver, Colorado, 80262
Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Fort Lauderdale, Florida, 33308
Pfizer Investigational Site
Galax, Virginia, 24333
Pfizer Investigational Site
Germantown, Tennessee, 38138
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Indianapolis, Indiana, 46202
Pfizer Investigational Site
Indianapolis, Indiana, 46260
Pfizer Investigational Site
Jacksonville, Florida, 32209
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Lebanon, New Hampshire, 03756
Pfizer Investigational Site
Lexington, Nebraska, 68850
Pfizer Investigational Site
Lincoln, Nebraska, 68516
Pfizer Investigational Site
Lorain, Ohio, 44053
Pfizer Investigational Site
Madison, Wisconsin, 53792
Pfizer Investigational Site
Manhasset, New York, 11030
Pfizer Investigational Site
McCook, Nebraska, 69001
Pfizer Investigational Site
Minneapolis, Minnesota, 55415
Pfizer Investigational Site
Minneapolis, Minnesota, 55422
Pfizer Investigational Site
Mount Airy, North Carolina, 27030
Pfizer Investigational Site
Nashville, Tennessee, 37212
Pfizer Investigational Site
New Haven, Connecticut, 06510
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Normal, Illinois, 61761
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73120
Pfizer Investigational Site
Pawtucket, Rhode Island, 02860
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107
Pfizer Investigational Site
Roanoke, Virginia, 24014
Pfizer Investigational Site
San Diego, California, 92103-8411
Pfizer Investigational Site
Sandusky, Ohio, 44870-3390
Pfizer Investigational Site
Santa Rosa, California, 95403
Pfizer Investigational Site
Sayre, Pennsylvania, 18840
Pfizer Investigational Site
St Louis, Missouri, 63104
Pfizer Investigational Site
St Louis, Missouri, 63110-0250
Pfizer Investigational Site
St Louis, Missouri, 63110
Pfizer Investigational Site
St Louis, Missouri, 63117
Pfizer Investigational Site
Walnut Creek, California, 94598-3084
Pfizer Investigational Site
West Islip, New York, 11795
Pfizer Investigational Site
Winston-Salem, North Carolina, 27109
About this study
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
The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure
- Conditions
- Heart Failure, Congestive
- Being tested
- Eplerenone
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between eplerenone and placebo in change from baseline in LV end diastolic volume index (EDVi) determined by equilibrium-gated radionuclide ventriculography (RVG)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2004 (estimated)
- Study startApr 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082589
- Sponsor's protocol ID
- A6141078
- Acronym
- REMODEL
- Status last verified
- Dec 2020
- First submitted
- 12 May 2004
- Last updated
- 22 Dec 2020
- Results posted
- No
Publications
Udelson JE, Feldman AM, Greenberg B, Pitt B, Mukherjee R, Solomon HA, Konstam MA. Randomized, double-blind, multicenter, placebo-controlled study evaluating the effect of aldosterone antagonism with eplerenone on ventricular remodeling in patients with mild-to-moderate heart failure and left ventricular systolic dysfunction. Circ Heart Fail. 2010 May;3(3):347-53. doi: 10.1161/CIRCHEARTFAILURE.109.906909. Epub 2010 Mar 18.
PubMed 20299607
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00082589
- Acronym / sponsor ID
- REMODEL / A6141078
- Conditions
- Heart Failure, Congestive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Mar 2006
- First posted
- 14 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eplerenone | Drug | – |
Primary outcome
Difference between eplerenone and placebo in change from baseline in LV end diastolic volume index (EDVi) determined by equilibrium-gated radionuclide ventriculography (RVG)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Derived from this study: PubMed 20299607Udelson JE, Feldman AM, Greenberg B, Pitt B, Mukherjee R, Solomon HA, Konstam MA. Randomized, double-blind, multicenter, placebo-controlled study evaluating the effect of aldosterone antagonism with eplerenone on ventricular remodeling in patients with mild-to-moderate heart failure and left ventricular systolic dysfunction. Circ Heart Fail. 2010 May;3(3):347-53. doi: 10.1161/CIRCHEARTFAILURE.109.906909. Epub 2010 Mar 18.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eplerenone in people with Heart Failure, Congestive, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 53 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between eplerenone and placebo in change from baseline in LV end diastolic volume index (EDVi) determined by equilibrium-gated radionuclide ventriculography (RVG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00082589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.