Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

A study to compare the efficacy and safety of eplerenone in Japanese chronic heart failure patients with placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Eplerenone; Spironolactone

Criteria

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:

• Patients with a myocardial infarction, stroke, cardiac surgery or percutaneous coronary intervention within 30 days prior to randomization.

• Patients with serum potassium >5.0 mmol/L or eGFR <30 ml/min/1.73 m2.