DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Failure

Intervention: Eplerenone (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Summary

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

Clinical Details

Official title: A Double-blind, Randomized, Placebo-controlled Trial Evaluating The Efficacy And Safety Of Eplerenone In Patinets With Chronic Heart Failure

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: First occurrence of cardiovascular mortality or heart failure hospitalization

Secondary outcome:

First occurrence of Cardiovascular (CV) mortality, heart failure (HF) hospitalization or Addition/Increase of HF medication due to HF worsening

All-cause mortality

CV mortality

All-cause hospitalization

HF hospitalization

All-cause mortality or all-cause hospitalization

HF mortality or HF hospitalization

CV hospitalization

Addition/Increase of HF medication due to HF worsening

Fatal/non-fatal myocardial infarction

Fatal/non-fatal stroke

New onset atrial fibrillation/flutter

New onset diabetes mellitus

Worsening renal function (if it results in hospitalization)

Hospitalization for hyperkalemia

Plasma BNP, Serum nt-BNP

LVEF

NYHA classification

Specific activity scale (SAS)

Eligibility

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Hamanomachi Hospital, Fukuoka 810-8539, Japan; Recruiting

Fukushima Medical University Hospital, Fukushima 960-1295, Japan; Recruiting

Gifu Prefectural General Medical Center, Gifu 500-8727, Japan; Recruiting

Tokushima Red Cross Hospital, Komatsushima 773-8502, Japan; Recruiting

Kumamoto University Hospital, Kumamoto 860-8556, Japan; Recruiting

Saiseikai Kumamoto Hospital, Kumamoto 861-4101, Japan; Terminated

Japanese Red Cross Okayama Hospital, Okayama 700-8607, Japan; Recruiting

National Hospital Organization Osaka National Hospital, Osaka 540-0006, Japan; Recruiting

Osaka General Medical Center, Osaka 558-8558, Japan; Recruiting

Osaka Police Hospital, Osaka 543-0035, Japan; Recruiting

Saitama Medical Center Jichi Medical University, Saitama 330-0834, Japan; Recruiting

National Hospital Organization Takasaki General Medical Center, Takasaki-shi 370-0829, Japan; Recruiting

Toyama University Hospital, Toyama 930-0152, Japan; Recruiting

Chubu Rosai Hospital, Nagoya, Aichi 455-8530, Japan; Recruiting

Tosei General Hospital, Seto, Aichi 489-8642, Japan; Recruiting

Asahi General Hospital, Asahi, Chiba 289-2511, Japan; Recruiting

Nippon Medical School Chiba Hokusou Hospital, Inzai, Chiba 270-1694, Japan; Recruiting

National Hospital Organization Chiba Medical Center, Chiba-shi, Chiba-ken, Japan; Terminated

Ehime Prefectural Central Hospital, Matuyama-shi, Ehime 790-0024, Japan; Recruiting

Kyushu University Hospital, Fukuoka-shi, Fukuoka-ken 812-8582, Japan; Recruiting

Aso Iizuka Hospital, Iizuka-shi, Fukuoka-ken 820-8505, Japan; Recruiting

Kurume University Hospital, Kurume-shi, Fukuoka-ken 830-0011, Japan; Terminated

Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic, Koriyama, Fukushima 963-8052, Japan; Recruiting

Ogaki Municipal Hospital, Ogaki, Gifu 503-8502, Japan; Recruiting

National Hospital Organization Hakodate National Hospital, Hakodate-shi, Hokkai-do 041-8512, Japan; Recruiting

Hakodate City Hospital, Hakodate, Hokkaido 041-8680, Japan; Recruiting

Hokkaido University Hospital, Sapporo, Hokkaido 060-8648, Japan; Recruiting

National Hospital Organization Hokkaido Medical Center, Sapporo, Hokkaido 063-0005, Japan; Recruiting

Teine Keijinkai Clinic, Sapporo, Hokkaido 006-0811, Japan; Terminated

Hyogo Brain and Heart Center, Himeji, Hyogo 670-0981, Japan; Recruiting

Japanease Red Cross Society Himeji Hospital, Himeji, Hyogo 670-8540, Japan; Recruiting

The Hospital of Hyogo College of Medicine, Nishinomiya, Hyogo 663-8501, Japan; Recruiting

Toride Kyodo General Hospital, Toride-shi, Ibaraki 302-0022, Japan; Recruiting

Mitoyo General Hospital, Kannonji, Kagawa 769-1695, Japan; Recruiting

Fujisawa City Hospital, Fujisawa, Kanagawa 251-8550, Japan; Recruiting

Kitasato University Hospital, Sagamihara, Kanagawa 252-0375, Japan; Recruiting

Mie University Hospital, Tsu, Mie 514-8507, Japan; Recruiting

National Hospital Organization Sendai Medical Center, Sendai-shi, Miyagi-ken 983-8520, Japan; Recruiting

Nara Medical University Hospital, Kashihara, Nara 634-8522, Japan; Recruiting

Kishiwada Tokushukai Hospital, Kishiwada, Osaka 596-0042, Japan; Recruiting

Sakai Municipal Hospital, Sakai-shi, Osaka 590-0064, Japan; Recruiting

Gokeikai Osaka Kaisei Hospital, Yodogawa-ku, Osaka 532-0003, Japan; Recruiting

National Cerebral and Cardiovascular Center Hospital, Suita-shi, Osaka-fu 565-8565, Japan; Recruiting

Shuwa General Hospital, Kasukabe-shi, Saitama 344-0035, Japan; Terminated

Kusatsu General Hospital, Kusatsu-shi, Shiga-ken 525-8585, Japan; Recruiting

Hamamatsu Rosai Hospital, Hamamatsu-shi, Shizuoka 430-8525, Japan; Terminated

Jichi Medical University Hospital, Shimotsuke-shi, Tochigi 329-0498, Japan; Recruiting

Juntendo University Hospital, Bunkyo-ku, Tokyo 113-8431, Japan; Recruiting

Mitsui Memorial Hospital, Chiyoda-Ku, Tokyo 101-8643, Japan; Recruiting

Tokyo Women's Medical University Hospital, Shinjuku-ku, Tokyo 162-8666, Japan; Recruiting

Tottori University Hospital, Yonago-shi, Tottori 683-8504, Japan; Terminated

UBE Industries, LTD. Central Hospital, Ube-shi, Yamaguchi 755-0151, Japan; Recruiting

Yamaguchi University Hospital, Ube, Yamaguchi 755-8505, Japan; Recruiting

University of Yamanashi Hospital, Chuo, Yamanashi 409-3898, Japan; Recruiting

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: July 2010
Last updated: February 9, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017