Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure
NCT ID: NCT01115855
Last Updated: 2020-12-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
221 participants
INTERVENTIONAL
2010-07-31
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Eplerenone arm
Add on standard heart failure therapy
Eplerenone
Eplerenone 25 mg once every other day, 25mg once daily or 50 mg once daily
Placebo arm
Add on standard heart failure therapy
Placebo
Placebo once daily or every once daily
Interventions
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Eplerenone
Eplerenone 25 mg once every other day, 25mg once daily or 50 mg once daily
Placebo
Placebo once daily or every once daily
Eligibility Criteria
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Inclusion Criteria
* Patients who receive standard therapy (Angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blocker or diuretic)
Exclusion Criteria
* Patients with serum potassium \>5.0 mmol/L or eGFR \<30 ml/min/1.73 m2.
55 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Chubu Rosai Hospital
Nagoya, Aichi-ken, Japan
Tosei General Hospital
Seto, Aichi-ken, Japan
Asahi General Hospital
Asahi, Chiba, Japan
National Hospital Organization Chiba Medical Center
Chiba, Chiba, Japan
Nippon Medical School Chiba Hokusou Hospital
Inzai, Chiba, Japan
Ehime Prefectural Central Hospital
Matuyama-shi, Ehime, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Aso Iizuka Hospital
Iizuka-shi, Fukuoka, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic
Kōriyama, Fukushima, Japan
Ogaki Municipal Hospital
Ōgaki, Gifu, Japan
National Hospital Organization Hakodate National Hospital
Hakodate-shi, Hokkai-do, Japan
Hakodate City Hospital
Hakodate, Hokkaido, Japan
Teine Keijinkai Clinic
Sapporo, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
National Hospital Organization Hokkaido Medical Center
Sapporo, Hokkaido, Japan
Hyogo Brain and Heart Center
Himeji, Hyōgo, Japan
Japanease Red Cross Society Himeji Hospital
Himeji, Hyōgo, Japan
The Hospital of Hyogo College of Medicine
Nishinomiya, Hyōgo, Japan
Toride Kyodo General Hospital
Toride-shi, Ibaraki, Japan
Mitoyo General Hospital
Kan’onjichō, Kagawa-ken, Japan
Fujisawa City Hospital
Fujisawa, Kanagawa, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, Japan
Sakai City Medical Center
Sakai-shi, Osaka, Japan
National Cerebral and Cardiovascular Center Hospital
Suita-shi, Osaka, Japan
Gokeikai Osaka Kaisei Hospital
Yodogawa-ku, Osaka, Japan
Shuwa General Hospital
Kasukabe-shi, Saitama, Japan
Saitama Medical Center Jichi Medical University
Saitama-shi, Saitama, Japan
Kusatsu General Hospital
Kusatsu-shi, Shiga, Japan
Hamamatsu Rosai Hospital
Hamamatsu, Shizuoka, Japan
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, Japan
Tokushima Red Cross Hospital
Komatsushimachō, Tokushima, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Mitsui Memorial Hospital
Chiyoda-Ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Tottori University Hospital
Yonago-shi, Tottori, Japan
Ube-kohsan Central Hospital Corp.
Ube, Yamaguchi, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
University of Yamanashi Hospital
Chūō, Yamanashi, Japan
Hamanomachi Hospital
Fukuoka, , Japan
Fukushima Medical University Hospital
Fukushima, , Japan
Gifu Prefectural General Medical Center
Gifu, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Saiseikai Kumamoto Hospital
Kumamoto, , Japan
Japanese Red Cross Okayama Hospital
Okayama, , Japan
National Hospital Organization Osaka National Hospital
Osaka, , Japan
Osaka Police Hospital
Osaka, , Japan
Osaka General Medical Center
Osaka, , Japan
National Hospital Organization Takasaki General Medical Center
Takasaki-shi, , Japan
Toyama University Hospital
Toyama, , Japan
Countries
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References
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Tsutsui H, Ito H, Kitakaze M, Komuro I, Murohara T, Izumi T, Sunagawa K, Yasumura Y, Yano M, Yamamoto K, Yoshikawa T, Tsutamoto T, Zhang J, Okayama A, Ichikawa Y, Kanmuri K, Matsuzaki M; J-EMPHASIS-HF Study Group. Double-Blind, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Eplerenone in Japanese Patients With Chronic Heart Failure (J-EMPHASIS-HF). Circ J. 2017 Dec 25;82(1):148-158. doi: 10.1253/circj.CJ-17-0323. Epub 2017 Aug 19.
Other Identifiers
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A6141114
Identifier Type: -
Identifier Source: org_study_id