Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure

NCT01115855 | Completed Phase 3 Results DMC

• 1 other identifier: A6141114
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 54

Brief Summary

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

Conditions

Heart Failure

Keywords

Double-blind; eplerenone; Japanese

Outcome Measures

Primary Outcomes (1)

• Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF)

  CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.

  Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

Secondary Outcomes (21)

• Number of Participants With First Occurrence of Cardiovascular (CV) Mortality, Hospitalization Due to Heart Failure (HF), or Addition/Increase of Heart Failure (HF) Medication

  Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

• Number of Participants With With First Occurrence of All-Cause Mortality

  Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

• Number of Participants With With First Occurrence of Cardiovascular Mortality

  Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

• Number of Participants With First Occurrence of All-cause Hospitalization

  Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

• Number of Participants With First Occurrence of Hospitalization Due to Heart Failure (HF)

  Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

Study Arms (2)

Eplerenone arm

EXPERIMENTAL

Add on standard heart failure therapy

Drug: Eplerenone

Placebo arm

PLACEBO COMPARATOR

Add on standard heart failure therapy

Drug: Placebo

Interventions

Eplerenone DRUG

Eplerenone 25 mg once every other day, 25mg once daily or 50 mg once daily

Eplerenone arm

Placebo DRUG

Placebo once daily or every once daily

Placebo arm

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (54)

Chubu Rosai Hospital

Nagoya, Aichi-ken, 455-8530, Japan

Location

Tosei General Hospital

Seto, Aichi-ken, 489-8642, Japan

Location

Asahi General Hospital

Asahi, Chiba, 289-2511, Japan

Location

National Hospital Organization Chiba Medical Center

Chiba, Chiba, 260-8606, Japan

Location

Nippon Medical School Chiba Hokusou Hospital

Inzai, Chiba, 270-1694, Japan

Location

Ehime Prefectural Central Hospital

Matuyama-shi, Ehime, 790-0024, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582, Japan

Location

Aso Iizuka Hospital

Iizuka-shi, Fukuoka, 820-8505, Japan

Location

Kurume University Hospital

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic

Kōriyama, Fukushima, 963-8052, Japan

Location

Ogaki Municipal Hospital

Ōgaki, Gifu, 503-8502, Japan

Location

National Hospital Organization Hakodate National Hospital

Hakodate-shi, Hokkai-do, 041-8512, Japan

Location

Hakodate City Hospital

Hakodate, Hokkaido, 041-8680, Japan

Location

Teine Keijinkai Clinic

Sapporo, Hokkaido, 006-0811, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

National Hospital Organization Hokkaido Medical Center

Sapporo, Hokkaido, 063-0005, Japan

Location

Hyogo Brain and Heart Center

Himeji, Hyōgo, 670-0981, Japan

Location

Japanease Red Cross Society Himeji Hospital

Himeji, Hyōgo, 670-8540, Japan

Location

The Hospital of Hyogo College of Medicine

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Toride Kyodo General Hospital

Toride-shi, Ibaraki, 302-0022, Japan

Location

Mitoyo General Hospital

Kan’onjichō, Kagawa-ken, 769-1695, Japan

Location

Fujisawa City Hospital

Fujisawa, Kanagawa, 251-8550, Japan

Location

Kitasato University Hospital

Sagamihara, Kanagawa, 252-0375, Japan

Location

Mie University Hospital

Tsu, Mie-ken, 514-8507, Japan

Location

National Hospital Organization Sendai Medical Center

Sendai, Miyagi, 983-8520, Japan

Location

Nara Medical University Hospital

Kashihara, Nara, 634-8522, Japan

Location

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, 596-0042, Japan

Location

Sakai City Medical Center

Sakai-shi, Osaka, 593-8304, Japan

Location

National Cerebral and Cardiovascular Center Hospital

Suita-shi, Osaka, 565-8565, Japan

Location

Gokeikai Osaka Kaisei Hospital

Yodogawa-ku, Osaka, 532-0003, Japan

Location

Shuwa General Hospital

Kasukabe-shi, Saitama, 344-0035, Japan

Location

Saitama Medical Center Jichi Medical University

Saitama-shi, Saitama, 330-0834, Japan

Location

Kusatsu General Hospital

Kusatsu-shi, Shiga, 525-8585, Japan

Location

Hamamatsu Rosai Hospital

Hamamatsu, Shizuoka, 430-8525, Japan

Location

Jichi Medical University Hospital

Shimotsuke-shi, Tochigi, 329-0498, Japan

Location

Tokushima Red Cross Hospital

Komatsushimachō, Tokushima, 773-8502, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Mitsui Memorial Hospital

Chiyoda-Ku, Tokyo, 101-8643, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

Tottori University Hospital

Yonago-shi, Tottori, 683-8504, Japan

Location

Ube-kohsan Central Hospital Corp.

Ube, Yamaguchi, 755-0151, Japan

Location

Yamaguchi University Hospital

Ube, Yamaguchi, 755-8505, Japan

Location

University of Yamanashi Hospital

Chūō, Yamanashi, 409-3898, Japan

Location

Hamanomachi Hospital

Fukuoka, 810-8539, Japan

Location

Fukushima Medical University Hospital

Fukushima, 960-1295, Japan

Location

Gifu Prefectural General Medical Center

Gifu, 500-8727, Japan

Location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Location

Saiseikai Kumamoto Hospital

Kumamoto, 861-4101, Japan

Location

Japanese Red Cross Okayama Hospital

Okayama, 700-8607, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, 540-0006, Japan

Location

Osaka Police Hospital

Osaka, 543-0035, Japan

Location

Osaka General Medical Center

Osaka, 558-8558, Japan

Location

National Hospital Organization Takasaki General Medical Center

Takasaki-shi, 370-0829, Japan

Location

Toyama University Hospital

Toyama, 930-0152, Japan

Location

Related Publications (1)

• 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.

  PMID: 28824029 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 4, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 22, 2020
• Results First Posted: October 27, 2016

Record last verified: 2020-12

Locations

JP (54)