Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01115855
First received: April 30, 2010
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Heart Failure
Drug: Eplerenone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Japanese Subjects With Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • First occurrence of cardiovascular mortality or heart failure hospitalization [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • First occurrence of Cardiovascular (CV) mortality, heart failure (HF) hospitalization or Addition/Increase of HF medication due to HF worsening [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • CV mortality [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • All-cause hospitalization [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • HF hospitalization [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • All-cause mortality or all-cause hospitalization [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • HF mortality or HF hospitalization [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • CV hospitalization [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Addition/Increase of HF medication due to HF worsening [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Fatal/non-fatal myocardial infarction [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Fatal/non-fatal stroke [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • New onset atrial fibrillation/flutter [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • New onset diabetes mellitus [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Worsening renal function (if it results in hospitalization) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Hospitalization for hyperkalemia [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Plasma BNP, Serum nt-BNP [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • LVEF [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • NYHA classification [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Specific activity scale (SAS) [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: July 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eplerenone arm
Add on standard heart failure therapy
Drug: Eplerenone
Eplerenone 25 mg once every other day, 25mg once daily or 50 mg once daily
Placebo Comparator: Placebo arm
Add on standard heart failure therapy
Drug: Placebo
Placebo once daily or every once daily

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115855

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 54 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01115855     History of Changes
Other Study ID Numbers: A6141114
Study First Received: April 30, 2010
Last Updated: September 10, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:
Double-blind
eplerenone
Japanese

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Eplerenone
Cardiovascular Agents
Diuretics
Diuretics, Potassium Sparing
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014