Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01115855
First received: April 30, 2010
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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 ]

Estimated Enrollment: 220
Study Start Date: July 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 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

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01115855

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
Japan
Chubu Rosai Hospital Recruiting
Nagoya, Aichi, Japan
Tosei General Hospital Recruiting
Seto, Aichi, Japan
National Hospital Organization Chiba Medical Center Terminated
Chiba-shi, Chiba-ken, Japan
Asahi General Hospital Recruiting
Asahi, Chiba, Japan
Nippon Medical School Chiba Hokusou Hospital Recruiting
Inzai, Chiba, Japan
Ehime Prefectural Central Hospital Recruiting
Matuyama-shi, Ehime, Japan
Kyushu University Hospital Recruiting
Fukuoka-shi, Fukuoka-ken, Japan
Aso Iizuka Hospital Recruiting
Iizuka-shi, Fukuoka-ken, Japan
Kurume University Hospital Terminated
Kurume-shi, Fukuoka-ken, Japan
Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic Recruiting
Koriyama, Fukushima, Japan
Ogaki Municipal Hospital Recruiting
Ogaki, Gifu, Japan
National Hospital Organization Hakodate National Hospital Recruiting
Hakodate-shi, Hokkai-do, Japan
Hakodate City Hospital Recruiting
Hakodate, Hokkaido, Japan
Hokkaido University Hospital Recruiting
Sapporo, Hokkaido, Japan
Teine Keijinkai Clinic Terminated
Sapporo, Hokkaido, Japan
National Hospital Organization Hokkaido Medical Center Recruiting
Sapporo, Hokkaido, Japan
Hyogo Brain and Heart Center Recruiting
Himeji, Hyogo, Japan
Japanease Red Cross Society Himeji Hospital Recruiting
Himeji, Hyogo, Japan
The Hospital of Hyogo College of Medicine Recruiting
Nishinomiya, Hyogo, Japan
Toride Kyodo General Hospital Recruiting
Toride-shi, Ibaraki, Japan
Mitoyo General Hospital Recruiting
Kannonji, Kagawa, Japan
Fujisawa City Hospital Recruiting
Fujisawa, Kanagawa, Japan
Kitasato University Hospital Recruiting
Sagamihara, Kanagawa, Japan
Mie University Hospital Recruiting
Tsu, Mie, Japan
National Hospital Organization Sendai Medical Center Recruiting
Sendai-shi, Miyagi-ken, Japan
Nara Medical University Hospital Recruiting
Kashihara, Nara, Japan
National Cerebral and Cardiovascular Center Hospital Recruiting
Suita-shi, Osaka-fu, Japan
Kishiwada Tokushukai Hospital Recruiting
Kishiwada, Osaka, Japan
Sakai Municipal Hospital Recruiting
Sakai-shi, Osaka, Japan
Gokeikai Osaka Kaisei Hospital Recruiting
Yodogawa-ku, Osaka, Japan
Shuwa General Hospital Terminated
Kasukabe-shi, Saitama, Japan
Kusatsu General Hospital Recruiting
Kusatsu-shi, Shiga-ken, Japan
Hamamatsu Rosai Hospital Terminated
Hamamatsu-shi, Shizuoka, Japan
Jichi Medical University Hospital Recruiting
Shimotsuke-shi, Tochigi, Japan
Juntendo University Hospital Recruiting
Bunkyo-ku, Tokyo, Japan
Mitsui Memorial Hospital Recruiting
Chiyoda-Ku, Tokyo, Japan
Tokyo Women's Medical University Hospital Recruiting
Shinjuku-ku, Tokyo, Japan
Tottori University Hospital Terminated
Yonago-shi, Tottori, Japan
Yamaguchi University Hospital Recruiting
Ube, Yamaguchi, Japan
UBE Industries, LTD. Central Hospital Recruiting
Ube-shi, Yamaguchi, Japan
University of Yamanashi Hospital Recruiting
Chuo, Yamanashi, Japan
Hamanomachi Hospital Recruiting
Fukuoka, Japan
Fukushima Medical University Hospital Recruiting
Fukushima, Japan
Gifu Prefectural General Medical Center Recruiting
Gifu, Japan
Tokushima Red Cross Hospital Recruiting
Komatsushima, Japan
Saiseikai Kumamoto Hospital Terminated
Kumamoto, Japan
Kumamoto University Hospital Recruiting
Kumamoto, Japan
Japanese Red Cross Okayama Hospital Recruiting
Okayama, Japan
Osaka General Medical Center Recruiting
Osaka, Japan
National Hospital Organization Osaka National Hospital Recruiting
Osaka, Japan
Osaka Police Hospital Recruiting
Osaka, Japan
Saitama Medical Center Jichi Medical University Recruiting
Saitama, Japan
National Hospital Organization Takasaki General Medical Center Recruiting
Takasaki-shi, Japan
Toyama University Hospital Recruiting
Toyama, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01115855     History of Changes
Other Study ID Numbers: A6141114
Study First Received: April 30, 2010
Last Updated: September 10, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:
Double-blind
eplerenone
Japanese

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014