Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure
NCT01115855
Last updated date
ABOUT THIS STUDY
A study to compare the efficacy and safety of eplerenone in Japanese chronic heart failure
patients with placebo.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
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
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 =<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
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 <30 ml/min/1.73 m2.
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- Strasbourg,
- Strasbourg,
- Valenciennes,
- Bad Nauheim,
- Bad Rothenfelde,
- Berlin,
- Berlin,
- Berlin,
- Berlin,
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- Duisburg,
- Essen,
- Frankfurt/Main,
- Goettingen,
- Hagen,
- Halle,
- Hannover,
- Homburg/Saar,
- Koeln,
- Leipzig,
- Ludwigshafen,
- Luebeck,
- Athens, Attika
- Haidari, Attiki
- Athens,
- Athens,
- Athens,
- Athens,
- Thessaloniki,
- Thessaloniki,
- Thessaloniki,
- Chai Wan,
- Pokfulam,
- Shatin NT,
- Budapest,
- Budapest,
- Budapest,
- Debrecen,
- Mosonmagyarovar,
- Siófok,
- Szeged,
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- Hyderabad, Andhra Pradesh
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- Bangalore, Karnataka
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- Ludhiana, Punjab
- Chennai, Tamil Nadu
- Coimbatore, Tamil Nadu
- Lucknow, Uttar Pradesh
- Cork,
- Dublin,
- Dublin,
- Galway,
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- Catania,
- Catania,
- Firenze,
- Mestre - Zelardino (VE),
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- Modena,
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure | |||
| Official Title ICMJE | The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Japanese Subjects With Chronic Heart Failure | |||
| Brief Summary | A study to compare the efficacy and safety of eplerenone in Japanese chronic heart failure patients with placebo. | |||
| Detailed Description | 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. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
| Condition ICMJE | Heart Failure | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 221 | |||
| Original Estimated Enrollment ICMJE | 220 | |||
| Actual Study Completion Date ICMJE | September 2015 | |||
| Actual Primary Completion Date | September 2015 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 55 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Japan | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01115855 | |||
| Other Study ID Numbers ICMJE | A6141114 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
| Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | December 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||