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Patient's Management Receiving Eplerenone Therapy (PERGAME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01440049
Recruitment Status : Completed
First Posted : September 26, 2011
Results First Posted : January 30, 2013
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Left Ventricular Dysfunction Post Myocardial Infarction
Intervention Other: Prospective Observational
Enrollment 160
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Eplerenone
Hide Arm/Group Description Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Period Title: Overall Study
Started 160
Completed 155
Not Completed 5
Reason Not Completed
Adverse Event             5
Arm/Group Title Eplerenone
Hide Arm/Group Description Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Baseline Participants 160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 160 participants
67.70  (11.72)
[1]
Measure Description: Out of a total of 160 participants, data for baseline measure (age) was available for only 159 participants.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants
Female
39
  24.4%
Male
121
  75.6%
1.Primary Outcome
Title Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population
Hide Description Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 127
Mean (Standard Deviation)
Unit of Measure: Percentage of EDV
41.2  (13.0)
2.Primary Outcome
Title Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population
Hide Description Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
SAS population included all participants who received study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 133
Mean (Standard Deviation)
Unit of Measure: Percentage of EDV
41.40  (12.82)
3.Primary Outcome
Title Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population
Hide Description Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
98.9
(94.0 to 99.8)
4.Primary Outcome
Title Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population
Hide Description Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 71
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
95.8
(88.3 to 98.6)
5.Primary Outcome
Title Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population
Hide Description Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
Time Frame Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 58
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
94.8
(85.9 to 98.2)
6.Primary Outcome
Title Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population
Hide Description Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
94.3
(86.2 to 97.8)
7.Primary Outcome
Title Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population
Hide Description Change of eplerenone dosage = modified dosage (mg daily) – dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 148
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Baseline: 10.7 mg daily dose (n=148)
0.7
(0.1 to 3.7)
Baseline: 12.5 mg daily dose (n=148)
3.4
(1.5 to 7.7)
Baseline: 25 mg daily dose (n=148)
84.5
(77.8 to 89.4)
Baseline: 50 mg daily dose (n=148)
11.5
(7.3 to 17.6)
Change at Month 3: Decrease (n=89)
4.5
(1.8 to 11.0)
Change at Month 3: No change (n=89)
76.4
(66.6 to 84.0)
Change at Month 3: Increase (n=89)
19.1
(12.3 to 28.5)
8.Primary Outcome
Title Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population
Hide Description Change of eplerenone dosage = modified dosage (mg daily) – dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 68
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Decrease
5.9
(2.3 to 14.2)
No change
70.6
(58.9 to 80.1)
Increase
23.5
(15.0 to 34.9)
9.Primary Outcome
Title Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population
Hide Description Change of eplerenone dosage = modified dosage (mg daily) – dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Time Frame Baseline, Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Decrease
7.3
(2.9 to 17.3)
No change
60.0
(46.8 to 71.9)
Increase
32.7
(21.8 to 45.9)
10.Primary Outcome
Title Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population
Hide Description Change of eplerenone dosage = modified dosage (mg daily) – dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Decrease
6.1
(2.4 to 14.6)
No change
78.8
(67.5 to 86.9)
Increase
15.2
(8.4 to 25.7)
11.Primary Outcome
Title Percentage of Participants Who Died in SAS Population
Hide Description [Not Specified]
Time Frame Baseline up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
SAS population included all participants who received study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 148
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
6.1
(3.2 to 11.2)
12.Primary Outcome
Title Percentage of Participants Hospitalized in FAS Population
Hide Description [Not Specified]
Time Frame Baseline up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 146
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
22.6
(16.6 to 30.0)
13.Primary Outcome
Title Number of Participants With Worsened Renal Function
Hide Description [Not Specified]
Time Frame Baseline up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed because the assessment of renal function was not included in the planned analysis of this study.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Number of Participants With Reason for Increased or Decreased Eplerenone Dose
Hide Description [Not Specified]
Time Frame Baseline up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not statistically summarized and were provided in individual participant listings as per the planned analysis.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Number of Participants With Concomitant Cardiovascular Treatment in FAS Population
Hide Description Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.
Time Frame Baseline up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 148
Measure Type: Number
Unit of Measure: Participants
143
16.Secondary Outcome
Title Number of Participants With Concomitant Cardiovascular Treatment in SAS Population
Hide Description Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.
Time Frame Baseline up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
SAS population included all participants who received study medication.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: Participants
144
17.Secondary Outcome
Title Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population
Hide Description [Not Specified]
Time Frame Baseline up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 143
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
13.3
(8.7 to 19.8)
18.Other Pre-specified Outcome
Title Percentage of Participants With Other Notable Events in FAS Population
Hide Description Other notable events included any clinically significant event other than death or hospitalization (example, ventricular tachycardia treated by defibrillator, imbalanced diabetes, work accident, right foot gout crisis, low back pain-oliguria, chest pain, bronchitis, renal failure, heart failure, hypotension, edema, standardization of gamma glutamyl transpeptidase (GT) after stopping lamisyl (peros) prescribed for a long term for mycosis, pain, nausea, fracture, trauma, gonarthrosis, increased urea, elevation of gamma GT etc.).
Time Frame Baseline up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 148
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
18.9
(13.4 to 26.0)
19.Other Pre-specified Outcome
Title Percentage of Participants With General Practitioner (GP) Consultation in FAS Population
Hide Description [Not Specified]
Time Frame Baseline up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 148
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
77.7
(70.3 to 83.7)
20.Other Pre-specified Outcome
Title Number of Measurements Per Month for Kalaemia Levels in FAS Population
Hide Description The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 millimole per liter (mmol/L). Number of measurements per month for the kalaemia levels was reported.
Time Frame Months 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed)= participants evaluable for this measure. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: Measurements per month
Month 3 (n=92) 0.5  (0.33)
Month 6 (n=71) 0.4  (0.27)
Month 9 (n=58) 0.3  (0.23)
Month 12 (n=70) 0.2  (0.17)
21.Other Pre-specified Outcome
Title Maximum Kalaemia Levels in Serum in FAS Population
Hide Description The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L.
Time Frame Baseline up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 127
Mean (Standard Deviation)
Unit of Measure: mmol/L
4.6  (0.56)
22.Other Pre-specified Outcome
Title Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population
Hide Description The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L. Change in maximum value kalaemia level was calculated by subtracting the baseline values from the maximum observed value of kalaemia levels during the study.
Time Frame Baseline up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed)= participants evaluable for this measure. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 140
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (n=140) 4.2  (0.38)
Change in maximum Kalaemia level (n=123) 0.4  (0.59)
23.Other Pre-specified Outcome
Title Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Hide Description New York Health Association (NYHA) functional classification included: Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity; fatigue, palpitation, or dyspnea with ordinary physical activity), Class III (marked limitation of physical activity; fatigue, palpitation, or dyspnea with less than ordinary physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Percentage of participants in each functional class was reported.
Time Frame Baseline, Months 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 148
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Baseline: Stage I (n=148)
16.9
(11.7 to 23.7)
Baseline: Stage II (n=148)
54.1
(46.0 to 61.9)
Baseline: Stage III (n=148)
28.4
(21.7 to 36.1)
Baseline: Stage IV (n=148)
0.7
(0.1 to 3.7)
Month 3: Stage I (n=91)
29.7
(21.3 to 39.7)
Month 3: Stage II (n=91)
61.5
(51.3 to 70.9)
Month 3: Stage III (n=91)
6.6
(3.1 to 13.6)
Month 3: Stage IV (n=91)
2.2
(0.6 to 7.7)
Month 6: Stage I (n=71)
23.9
(15.5 to 35.0)
Month 6: Stage II (n=71)
64.8
(53.2 to 74.9)
Month 6: Stage III (n=71)
8.5
(3.9 to 17.2)
Month 6: Stage IV (n=71)
2.8
(0.8 to 9.7)
Month 9: Stage I (n=58)
22.4
(13.6 to 34.7)
Month 9: Stage II (n=58)
65.5
(52.7 to 76.4)
Month 9: Stage III (n=58)
12.1
(6.0 to 22.9)
Month 12: Stage I (n=70)
27.1
(18.1 to 38.5)
Month 12: Stage II (n=70)
64.3
(52.6 to 74.5)
Month 12: Stage III (n=70)
8.6
(4.0 to 17.5)
24.Other Pre-specified Outcome
Title Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population
Hide Description Reasons for starting eplerenone treatment included myocardial infarction, heart failure and other conditions including severe hypertension by primary hyperaldosteronism; hypertension/coronaropathy and hypokalaemia; hypertension; left ventricular failure; not tolerated spironolactone; hypertension: gynecomastia with aldactone; pulmonary suboedema; hypertension: adrenal hyperplasia, gynecomastia with aldactone; hypertension not controlled.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
Overall Number of Participants Analyzed 147
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Myocardial infarction
61.9
(53.8 to 69.4)
Heart failure
29.9
(23.1 to 37.8)
For another condition
4.8
(2.3 to 9.5)
Myocardial infarction and heart failure
3.4
(1.5 to 7.7)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Eplerenone
Hide Arm/Group Description Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
All-Cause Mortality
Eplerenone
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eplerenone
Affected / at Risk (%)
Total   17/160 (10.63%) 
Blood and lymphatic system disorders   
Iron deficiency anaemia * 1  1/160 (0.63%) 
Cardiac disorders   
Acute coronary syndrome * 1  1/160 (0.63%) 
Cardiac failure * 1  3/160 (1.88%) 
Cardiac failure acute * 1  1/160 (0.63%) 
Cardiac flutter * 1  1/160 (0.63%) 
Cardiogenic shock * 1  1/160 (0.63%) 
Coronary artery thrombosis * 1  1/160 (0.63%) 
Myocardial infarction * 1  1/160 (0.63%) 
Ventricular tachycardia * 1  1/160 (0.63%) 
Gastrointestinal disorders   
Gastrointestinal haemorrhage * 1  1/160 (0.63%) 
Intestinal polyp * 1  1/160 (0.63%) 
General disorders   
Death * 1  2/160 (1.25%) 
Sudden death * 1  2/160 (1.25%) 
Hepatobiliary disorders   
Cholangitis * 1  1/160 (0.63%) 
Infections and infestations   
Erysipelas * 1  1/160 (0.63%) 
Investigations   
Ejection fraction decreased * 1  1/160 (0.63%) 
Nervous system disorders   
Cerebrovascular accident * 1  1/160 (0.63%) 
Presyncope * 1  1/160 (0.63%) 
Respiratory, thoracic and mediastinal disorders   
Acute pulmonary oedema * 1  2/160 (1.25%) 
Dyspnoea * 1  1/160 (0.63%) 
Surgical and medical procedures   
Coronary artery bypass * 1  1/160 (0.63%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Eplerenone
Affected / at Risk (%)
Total   20/160 (12.50%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/160 (0.63%) 
Cardiac disorders   
Angina pectoris * 1  1/160 (0.63%) 
Atrial fibrillation * 1  1/160 (0.63%) 
Cardiac failure acute * 1  2/160 (1.25%) 
Ventricular tachycardia * 1  1/160 (0.63%) 
Gastrointestinal disorders   
Gastrointestinal haemorrhage * 1  1/160 (0.63%) 
General disorders   
Chest pain * 1  1/160 (0.63%) 
Condition aggravated * 1  1/160 (0.63%) 
Missing code * 1  1/160 (0.63%) 
Infections and infestations   
Bronchitis * 1  3/160 (1.88%) 
Injury, poisoning and procedural complications   
Ankle fracture * 1  1/160 (0.63%) 
Chest injury * 1  1/160 (0.63%) 
Rib fracture * 1  1/160 (0.63%) 
Investigations   
Arteriogram coronary * 1  1/160 (0.63%) 
Gamma-glutamyltransferase increased * 1  1/160 (0.63%) 
Metabolism and nutrition disorders   
Diabetes mellitus inadequate control * 1  1/160 (0.63%) 
Gout * 1  1/160 (0.63%) 
Hyponatraemia * 1  1/160 (0.63%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/160 (0.63%) 
Renal and urinary disorders   
Renal colic * 1  1/160 (0.63%) 
Renal failure * 1  3/160 (1.88%) 
Reproductive system and breast disorders   
Gynaecomastia * 1  1/160 (0.63%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure * 1  1/160 (0.63%) 
Bronchopneumopathy * 1  1/160 (0.63%) 
Cough * 1  1/160 (0.63%) 
Pleural effusion * 1  1/160 (0.63%) 
Surgical and medical procedures   
Coronary angioplasty * 1  1/160 (0.63%) 
Endarterectomy * 1  1/160 (0.63%) 
Implantable defibrillator insertion * 1  1/160 (0.63%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01440049     History of Changes
Other Study ID Numbers: NRA6140035
First Submitted: September 14, 2011
First Posted: September 26, 2011
Results First Submitted: December 21, 2012
Results First Posted: January 30, 2013
Last Update Posted: December 19, 2018