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Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Chubu Rosai Hospital
Nagoya, Aichi, 455-8530 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Heart Failure
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
55+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Japanese chronic systolic heart failure patients with LVEF = and NYHA II or more

- Patients who receive standard therapy (Angiotensin converting enzyme inhibitors,
angiotensin receptor blockers, beta-blocker or diuretic)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01115855
Pfizer
Completed
Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure

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Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure
The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Japanese Subjects With Chronic Heart Failure
A study to compare the efficacy and safety of eplerenone in Japanese chronic heart failure patients with placebo.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure
  • Drug: Eplerenone
    Eplerenone 25 mg once every other day, 25mg once daily or 50 mg once daily
  • Drug: Placebo
    Placebo once daily or every once daily
  • Experimental: Eplerenone arm
    Add on standard heart failure therapy
    Intervention: Drug: Eplerenone
  • Placebo Comparator: Placebo arm
    Add on standard heart failure therapy
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
221
September 2015
September 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01115855
A6141114
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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