Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01115855
First received: April 30, 2010
Last updated: July 9, 2014
Last verified: July 2014

April 30, 2010
July 9, 2014
July 2010
December 2015   (final data collection date for primary outcome measure)
First occurrence of cardiovascular mortality or heart failure hospitalization [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01115855 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure
The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Japanese Subjects With Chronic Heart Failure

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure
  • Drug: Eplerenone
    Eplerenone 25 mg once every other day, 25mg once daily or 50 mg once daily
  • Drug: Placebo
    Placebo once daily or every once daily
  • Experimental: Eplerenone arm
    Add on standard heart failure therapy
    Intervention: Drug: Eplerenone
  • Placebo Comparator: Placebo arm
    Add on standard heart failure therapy
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
December 2015
December 2015   (final data collection date for primary outcome measure)

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.
Both
55 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Japan
 
NCT01115855
A6141114
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP