Home
Search
Study Topics
Glossary
|
Study 6 of 18 for search of: | United Arab Emirates |
Previous Study | Return to Search Results | Next Study |
|
|
|
|
|
Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00232180 |
In an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack. However, it is not known how patients with established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus standard heart failure medicines is being compared to placebo plus standard heart failure medicines in terms of an additional ability to prolong life and prevent re-hospitalizations for worsening heart failure in these patients
Condition | Intervention | Phase |
---|---|---|
Heart Failure |
Drug: Eplerenone Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Effect of Eplerenone Versus Placebo on Cardiovascular Mortality and Heart Failure Hospitalization in Subjects With NYHA Class II Chronic Systolic Heart Failure |
Estimated Enrollment: | 2584 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Eplerenone arm: Active Comparator
Eplerenone administered on top of background standard heart failure therapy
|
Drug: Eplerenone
Eplerenone administered on top of background standard heart failure therapy
|
Placebo arm: Placebo Comparator
Placebo administered on top of background standard heart failure therapy
|
Drug: Placebo
Placebo administered on top of background standard heart failure therapy
|
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A6141079 |
Study First Received: | September 30, 2005 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00232180 |
Health Authority: | United States: Food and Drug Administration |
Double-blind, parallel group, mortality/morbidity trial, eplerenone, chronic systolic heart failure |
Eplerenone Heart Failure Heart Diseases Heart Failure, Systolic |
Aldosterone Antagonists Hormone Antagonists Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Cardiovascular Diseases Pharmacologic Actions |