Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Pfizer
Information provided by (Responsible Party):
Pfizer Identifier:
First received: April 30, 2010
Last updated: September 4, 2015
Last verified: September 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: A Double-blind, Randomized, Placebo-controlled Trial Evaluating The Efficacy And Safety Of Eplerenone In Patinets 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: September 2015
Estimated 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
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

Contact: Pfizer Call Center 1-800-718-1021

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

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT01115855     History of Changes
Other Study ID Numbers: A6141114
Study First Received: April 30, 2010
Last Updated: September 4, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Cardiovascular Agents
Diuretics, Potassium Sparing
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on October 02, 2015