Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure

Last updated: December 19, 2020
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Overall Status: Completed

Phase

3

Condition

Chest Pain

Congestive Heart Failure

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT01115855
A6141114
  • Ages > 55
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Japanese chronic systolic heart failure patients with LVEF =<30% by echocardiographyand NYHA II or more
  • Patients who receive standard therapy (Angiotensin converting enzyme inhibitors,angiotensin receptor blockers, beta-blocker or diuretic)

Exclusion

Exclusion Criteria:

  • Patients with a myocardial infarction, stroke, cardiac surgery or percutaneouscoronary intervention within 30 days prior to randomization.
  • Patients with serum potassium >5.0 mmol/L or eGFR <30 ml/min/1.73 m2.

Study Design

Total Participants: 221
Study Start date:
July 01, 2010
Estimated Completion Date:
September 30, 2015

Study Description

The aim of this study was to show consistency with the EMPHASIS-HF trial (NCT00232180), which was defined as a HR of the primary endpoint of below 1.

Connect with a study center

  • Chubu Rosai Hospital

    Nagoya, Aichi 455-8530
    Japan

    Site Not Available

  • Tosei General Hospital

    Seto, Aichi 489-8642
    Japan

    Site Not Available

  • Asahi General Hospital

    Asahi, Chiba 289-2511
    Japan

    Site Not Available

  • Nippon Medical School Chiba Hokusou Hospital

    Inzai, Chiba 270-1694
    Japan

    Site Not Available

  • National Hospital Organization Chiba Medical Center

    Chiba-shi, Chiba-ken 260-8606
    Japan

    Site Not Available

  • Ehime Prefectural Central Hospital

    Matuyama-shi, Ehime 790-0024
    Japan

    Site Not Available

  • Kyushu University Hospital

    Fukuoka-shi, Fukuoka-ken 812-8582
    Japan

    Site Not Available

  • Aso Iizuka Hospital

    Iizuka-shi, Fukuoka-ken 820-8505
    Japan

    Site Not Available

  • Kurume University Hospital

    Kurume-shi, Fukuoka-ken 830-0011
    Japan

    Site Not Available

  • Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic

    Koriyama, Fukushima 963-8052
    Japan

    Site Not Available

  • Ogaki Municipal Hospital

    Ogaki, Gifu 503-8502
    Japan

    Site Not Available

  • National Hospital Organization Hakodate National Hospital

    Hakodate-shi, Hokkai-do 041-8512
    Japan

    Site Not Available

  • Hakodate City Hospital

    Hakodate, Hokkaido 041-8680
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo, Hokkaido 060-8648
    Japan

    Site Not Available

  • National Hospital Organization Hokkaido Medical Center

    Sapporo, Hokkaido 063-0005
    Japan

    Site Not Available

  • Teine Keijinkai Clinic

    Sapporo, Hokkaido 006-0811
    Japan

    Site Not Available

  • Hyogo Brain and Heart Center

    Himeji, Hyogo 670-0981
    Japan

    Site Not Available

  • Japanease Red Cross Society Himeji Hospital

    Himeji, Hyogo 670-8540
    Japan

    Site Not Available

  • The Hospital of Hyogo College of Medicine

    Nishinomiya, Hyogo 663-8501
    Japan

    Site Not Available

  • Toride Kyodo General Hospital

    Toride-shi, Ibaraki 302-0022
    Japan

    Site Not Available

  • Mitoyo General Hospital

    Kannonji, Kagawa 769-1695
    Japan

    Site Not Available

  • Fujisawa City Hospital

    Fujisawa, Kanagawa 251-8550
    Japan

    Site Not Available

  • Kitasato University Hospital

    Sagamihara, Kanagawa 252-0375
    Japan

    Site Not Available

  • Mie University Hospital

    Tsu, MIE 514-8507
    Japan

    Site Not Available

  • National Hospital Organization Sendai Medical Center

    Sendai-shi, Miyagi-ken 983-8520
    Japan

    Site Not Available

  • Shinshu University Hospital

    Matsumoto, Nagano
    Japan

    Site Not Available

  • Nara Medical University Hospital

    Kashihara, Nara 634-8522
    Japan

    Site Not Available

  • Kishiwada Tokushukai Hospital

    Kishiwada, Osaka 596-0042
    Japan

    Site Not Available

  • Kinki University Hospital

    Osakasayama, Osaka
    Japan

    Site Not Available

  • Sakai City Medical Center

    Sakai-shi, Osaka 593-8304
    Japan

    Site Not Available

  • Gokeikai Osaka Kaisei Hospital

    Yodogawa-ku, Osaka 532-0003
    Japan

    Site Not Available

  • National Cerebral and Cardiovascular Center Hospital

    Suita-shi, Osaka-fu 565-8565
    Japan

    Site Not Available

  • Shuwa General Hospital

    Kasukabe-shi, Saitama 344-0035
    Japan

    Site Not Available

  • Saitama Medical Center Jichi Medical University

    Saitama-shi, Saitama 330-0834
    Japan

    Site Not Available

  • Kusatsu General Hospital

    Kusatsu-shi, Shiga-ken 525-8585
    Japan

    Site Not Available

  • Hamamatsu Rosai Hospital

    Hamamatsu-shi, Shizuoka 430-8525
    Japan

    Site Not Available

  • National Hospital Organization Shizuoka Medical Center

    Sunto, Shizuoka
    Japan

    Site Not Available

  • Jichi Medical University Hospital

    Shimotsuke-shi, Tochigi 329-0498
    Japan

    Site Not Available

  • Tokushima Red Cross Hospital

    Komatsushima, Tokushima 773-8502
    Japan

    Site Not Available

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo 113-8431
    Japan

    Site Not Available

  • Mitsui Memorial Hospital

    Chiyoda-Ku, Tokyo 101-8643
    Japan

    Site Not Available

  • Showa University Hospital

    Shinagawa-ku, Tokyo
    Japan

    Site Not Available

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo 162-8666
    Japan

    Site Not Available

  • Keio University Hospital

    Shinjyuku-ku, Tokyo
    Japan

    Site Not Available

  • Tottori University Hospital

    Yonago-shi, Tottori 683-8504
    Japan

    Site Not Available

  • Yamaguchi University Hospital

    Ube, Yamaguchi 755-8505
    Japan

    Site Not Available

  • Ube-kohsan Central Hospital Corp.

    Ube-city, Yamaguchi 755-0151
    Japan

    Site Not Available

  • UBE Industries, LTD. Central Hospital

    Ube-shi, Yamaguchi
    Japan

    Site Not Available

  • University of Yamanashi Hospital

    Chuo, Yamanashi 409-3898
    Japan

    Site Not Available

  • Hamanomachi Hospital

    Fukuoka, 810-8539
    Japan

    Site Not Available

  • Fukushima Medical University Hospital

    Fukushima, 960-1295
    Japan

    Site Not Available

  • Gifu Prefectural General Medical Center

    Gifu, 500-8727
    Japan

    Site Not Available

  • Kumamoto University Hospital

    Kumamoto, 860-8556
    Japan

    Site Not Available

  • Saiseikai Kumamoto Hospital

    Kumamoto, 861-4101
    Japan

    Site Not Available

  • Japanese Red Cross Okayama Hospital

    Okayama, 700-8607
    Japan

    Site Not Available

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006
    Japan

    Site Not Available

  • Osaka General Medical Center

    Osaka, 558-8558
    Japan

    Site Not Available

  • Osaka Police Hospital

    Osaka, 543-0035
    Japan

    Site Not Available

  • Saitama Medical Center Jichi Medical University

    Saitama,
    Japan

    Site Not Available

  • National Hospital Organization Takasaki General Medical Center

    Takasaki-shi, 370-0829
    Japan

    Site Not Available

  • Toyama University Hospital

    Toyama, 930-0152
    Japan

    Site Not Available

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