Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Eplerenone · 4 trials · 2 indications
CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.
CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.
| Arm | Type | Description |
|---|---|---|
| Eplerenone arm | EXPERIMENTAL | Add on standard heart failure therapy |
| Placebo arm | PLACEBO_COMPARATOR | Add on standard heart failure therapy |
| Name | Type | Description |
|---|---|---|
| Eplerenone | DRUG | Eplerenone 25 mg once every other day, 25mg once daily or 50 mg once daily |
| Placebo | DRUG | Placebo once daily or every once daily |
Inclusion Criteria: * Japanese chronic systolic heart failure patients with LVEF =\<30% by echocardiography and NYHA II or more * Patients who receive standard therapy (Angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blocker or diuretic) Exclusion Criteria: * Patient...
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Eplerenone is a small molecule used for hypertension and heart failure. It is being developed by Pfizer, Inc. for these cardiovascular conditions. The drug is currently in Phase 3 clinical development, meaning it is investigational and not yet approved for these uses.
Eplerenone is a small molecule that targets the mineralocorticoid receptor, blocking aldosterone's effects. This action helps treat hypertension and heart failure by reducing sodium retention and fluid buildup, which lowers blood pressure and decreases strain on the heart.
Eplerenone is developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker PFE. Pfizer is conducting Phase 3 clinical trials for this drug in hypertension and heart failure.
Eplerenone is in Phase 3 clinical development. It is an investigational drug for hypertension and heart failure, meaning it has not yet received FDA approval. All four Phase 3 trials for Eplerenone have been completed.
Eplerenone has completed four Phase 3 trials. NCT00147589 and NCT00147615 studied hypertension in children aged 6 to 16 years. NCT00232180 and NCT01115855 studied heart failure in adults aged 55 years and older. All trials are completed.
Eplerenone is the generic name for the drug marketed as Inspra. The clinical trials listed under Eplerenone, such as NCT00232180 for heart failure, refer to this same compound. Pfizer develops Eplerenone under this generic name.