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Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: April 30, 2010
Last updated: October 6, 2015
Last verified: October 2015
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 ]

Enrollment: 221
Study Start Date: July 2010
Study Completion Date: September 2015
Primary Completion Date: September 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


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01115855

  Hide Study Locations
Chubu Rosai Hospital
Nagoya, Aichi, Japan, 455-8530
Tosei General Hospital
Seto, Aichi, Japan, 489-8642
National Hospital Organization Chiba Medical Center
Chiba-shi, Chiba-ken, Japan
Asahi General Hospital
Asahi, Chiba, Japan, 289-2511
Nippon Medical School Chiba Hokusou Hospital
Inzai, Chiba, Japan, 270-1694
Ehime Prefectural Central Hospital
Matuyama-shi, Ehime, Japan, 790-0024
Kyushu University Hospital
Fukuoka-shi, Fukuoka-ken, Japan, 812-8582
Aso Iizuka Hospital
Iizuka-shi, Fukuoka-ken, Japan, 820-8505
Kurume University Hospital
Kurume-shi, Fukuoka-ken, Japan, 830-0011
Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic
Koriyama, Fukushima, Japan, 963-8052
Ogaki Municipal Hospital
Ogaki, Gifu, Japan, 503-8502
National Hospital Organization Hakodate National Hospital
Hakodate-shi, Hokkai-do, Japan, 041-8512
Hakodate City Hospital
Hakodate, Hokkaido, Japan, 041-8680
Teine Keijinkai Clinic
Sapporo, Hokkaido, Japan, 006-0811
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
National Hospital Organization Hokkaido Medical Center
Sapporo, Hokkaido, Japan, 063-0005
Hyogo Brain and Heart Center
Himeji, Hyogo, Japan, 670-0981
Japanease Red Cross Society Himeji Hospital
Himeji, Hyogo, Japan, 670-8540
The Hospital of Hyogo College of Medicine
Nishinomiya, Hyogo, Japan, 663-8501
Toride Kyodo General Hospital
Toride-shi, Ibaraki, Japan, 302-0022
Mitoyo General Hospital
Kannonji, Kagawa, Japan, 769-1695
Fujisawa City Hospital
Fujisawa, Kanagawa, Japan, 251-8550
Kitasato University Hospital
Sagamihara, Kanagawa, Japan, 252-0375
Mie University Hospital
Tsu, Mie, Japan, 514-8507
National Hospital Organization Sendai Medical Center
Sendai-shi, Miyagi-ken, Japan, 983-8520
Nara Medical University Hospital
Kashihara, Nara, Japan, 634-8522
National Cerebral and Cardiovascular Center Hospital
Suita-shi, Osaka-fu, Japan, 565-8565
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, Japan, 596-0042
Sakai Municipal Hospital
Sakai-shi, Osaka, Japan, 590-0064
Gokeikai Osaka Kaisei Hospital
Yodogawa-ku, Osaka, Japan, 532-0003
Shuwa General Hospital
Kasukabe-shi, Saitama, Japan, 344-0035
Kusatsu General Hospital
Kusatsu-shi, Shiga-ken, Japan, 525-8585
Hamamatsu Rosai Hospital
Hamamatsu-shi, Shizuoka, Japan, 430-8525
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, Japan, 329-0498
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8431
Mitsui Memorial Hospital
Chiyoda-Ku, Tokyo, Japan, 101-8643
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 162-8666
Tottori University Hospital
Yonago-shi, Tottori, Japan, 683-8504
UBE Industries, LTD. Central Hospital
Ube-shi, Yamaguchi, Japan, 755-0151
Yamaguchi University Hospital
Ube, Yamaguchi, Japan, 755-8505
University of Yamanashi Hospital
Chuo, Yamanashi, Japan, 409-3898
Hamanomachi Hospital
Fukuoka, Japan, 810-8539
Fukushima Medical University Hospital
Fukushima, Japan, 960-1295
Gifu Prefectural General Medical Center
Gifu, Japan, 500-8727
Tokushima Red Cross Hospital
Komatsushima, Japan, 773-8502
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Saiseikai Kumamoto Hospital
Kumamoto, Japan, 861-4101
Japanese Red Cross Okayama Hospital
Okayama, Japan, 700-8607
National Hospital Organization Osaka National Hospital
Osaka, Japan, 540-0006
Osaka Police Hospital
Osaka, Japan, 543-0035
Osaka General Medical Center
Osaka, Japan, 558-8558
Saitama Medical Center Jichi Medical University
Saitama, Japan, 330-0834
National Hospital Organization Takasaki General Medical Center
Takasaki-shi, Japan, 370-0829
Toyama University Hospital
Toyama, Japan, 930-0152
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01115855     History of Changes
Other Study ID Numbers: A6141114 
Study First Received: April 30, 2010
Last Updated: October 6, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents processed this record on October 21, 2016