Study start date: April 1, 2004Actual date on which the first participant was enrolled.
The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure
Official TitleA 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
Principal SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
250 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
How participants are assigned to different groups/arms In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.
Other Ways to Assign Participants Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision. None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.
How treatments are given to participants In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.
Other Ways to Assign Treatments Parallel assignment: Participants are split into separate groups, each receiving a different treatment. Cross-over assignment: Participants switch between treatments during the study. Factorial assignment: Participants receive different combinations of treatments. Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses. Other assignment: Treatment assignment does not follow a standard or predefined design.
How the interventions assigned to participants is kept confidential Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.
Other Ways to Mask Information Open-label: Everyone knows which treatment is being given. Single-blind: Participants do not know which treatment they are receiving, but researchers do. Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given. Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 21 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Heart Failure, Congestive
Criteria
3 inclusion criteria required to participate
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
2 exclusion criteria prevent from participating
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 53 locations
Suspended
Pfizer Investigational SiteCastro Valley, United StatesSee the location
Suspended
Pfizer Investigational SiteSan Diego, United States
Suspended
Pfizer Investigational SiteSanta Rosa, United States
Suspended
Pfizer Investigational SiteWalnut Creek, United States