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Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure (J-EMPHASIS-HF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01115855
First received: April 30, 2010
Last updated: September 5, 2016
Last verified: September 2016
Results First Received: September 5, 2016  
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
Condition: Heart Failure
Interventions: Drug: Eplerenone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Eplerenone Participants with estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 50 milliliter per minute divided by 1.73 squared meter (mL/min/1.73m^2) received eplerenone 25 milligram (mg) tablet once daily up to Week 4 and participants with eGFR 30 to less than (<) 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. . From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
Placebo Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Participant Flow:   Overall Study
    Eplerenone   Placebo
STARTED   111   110 
COMPLETED   75   74 
NOT COMPLETED   36   36 
Adverse Event                16                18 
Death                6                5 
Lab Abnormality                1                1 
Protocol Violation                0                1 
Withdrawal by Subject                5                5 
Unspecified                8                6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set included all randomized participants.

Reporting Groups
  Description
Eplerenone Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
Placebo Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
Total Total of all reporting groups

Baseline Measures
    Eplerenone   Placebo   Total
Overall Participants Analyzed 
[Units: Participants]
 111   110   221 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.0  (8.7)   68.4  (7.7)   68.7  (8.2) 
Gender 
[Units: Participants]
     
Female   26   19   45 
Male   85   91   176 


  Outcome Measures
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1.  Primary:   Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF)   [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]

2.  Secondary:   Number of Participants With First Occurrence of Cardiovascular (CV) Mortality, Hospitalization Due to Heart Failure (HF), or Addition/Increase of Heart Failure (HF) Medication   [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]

3.  Secondary:   Number of Participants With With First Occurrence of All-Cause Mortality   [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]

4.  Secondary:   Number of Participants With With First Occurrence of Cardiovascular Mortality   [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]

5.  Secondary:   Number of Participants With First Occurrence of All-cause Hospitalization   [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]

6.  Secondary:   Number of Participants With First Occurrence of Hospitalization Due to Heart Failure (HF)   [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]

7.  Secondary:   Number of Participants With First Occurrence of All-cause Mortality or All-cause Hospitalization   [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]

8.  Secondary:   Number of Participants With First Occurrence of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization   [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]

9.  Secondary:   Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization   [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]

10.  Secondary:   Number of Participants With First Occurrence of Addition/Increase of Heart Failure (HF) Medication Due to Heart Failure (HF) Worsening   [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]

11.  Secondary:   Number of Participants With First Occurrence of Fatal/Non-Fatal Stroke   [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]

12.  Secondary:   Number of Participants With First Occurrence of Fatal/Non-Fatal Myocardial Infarction (MI)   [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]

13.  Secondary:   Number of Participants With First Occurrence of New Onset Atrial Fibrillation/Flutter   [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]

14.  Secondary:   Number of Participants With First Occurrence of New Onset Diabetes Mellitus   [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]

15.  Secondary:   Number of Participants With First Occurrence of Hospitalisation Due to Worsening Renal Function   [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]

16.  Secondary:   Number of Participants With First Occurrence of Hospitalization for Hyperkalemia   [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]

17.  Secondary:   Change From Baseline in Plasma Concentration of Brain Natriuretic Peptide at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit   [ Time Frame: Baseline, Months 5,9,13,17,21,25,29,33,37,42,48, Final Visit (up to Month 48) ]

18.  Secondary:   Change From Baseline in Plasma Concentration of Serum N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit   [ Time Frame: Baseline, Months 5, 9, 13, 17, 21 ,25, 29, 33, 37, 42, 48 and Final Visit (up to Month 48) ]

19.  Secondary:   Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit   [ Time Frame: Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48) ]

20.  Secondary:   Change From Baseline in Urine Albumin-to-Creatinine Ratio at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit   [ Time Frame: Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48) ]

21.  Secondary:   Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Weeks 1, 4, Months 2, 3, 4, 5, 9, 13, 17 21, 25, 29, 33, 37, 42, 48 and Final Visit   [ Time Frame: Baseline, Weeks 1, 4, Months 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit (up to Month 48) ]

22.  Secondary:   Change From Baseline in Specific Activity Scale (SAS) Score at Week 4, Months 2, 3, 4, 5, 9, 13, 17 21, 25, 29, 33, 37, 42, 48 and Final Visit   [ Time Frame: Baseline, Week 4, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01115855     History of Changes
Other Study ID Numbers: A6141114
Study First Received: April 30, 2010
Results First Received: September 5, 2016
Last Updated: September 5, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare