Hypertension
Conditions
Keywords
Eplerenone, Selara, Hypertension, Good post-marketing study Practice, Drug use Investigation, Regulatory Post Marketing Commitment Plan, ESSENCE
Brief summary
To collect the efficacy and safety information of Eplerenone on patients with hypertension related to their appropriate use in daily practice.
Interventions
DRUGSelara
Treatment should be initiated at 25 mg once daily and titrated to the recommended dose of 50 mg once daily, preferably within 4 weeks as tolerated by the patient. Selara may be administered with or without food.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male or Female patients who are prescribed Selara tablet for Hypertension.
Exclusion criteria
* Subjects who have been prescribed Selara tablet.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Related Adverse Events. | 12 weeks | Adverse events mean all unfavorable events that occur in participants after administration of Selara, irrespective of causal relationship to Selara (including clinically problematic abnormal changes in laboratory test values). Treatment Related Adverse Events were evaluated in company with the causal relationship to Selara. |
| Number of Participants With Serious Treatment Related Adverse Events. | 12 weeks | Serious treatment related adverse events mean those that may lead to death, life-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure Over Time. | 12 weeks | The primary analysis item was the mean systolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely. |
| Change in Diastolic Blood Pressure Over Time. | 12 weeks | The primary analysis item was the mean diastolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely. |
| Number of Participants That Responded to Selara Treatment. | 12 weeks | Number of participants among the efficacy analysis population that responded to Selara treatment. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Selara Participants taking Selara according to Japanese Package Insert. | 3,210 |
| Total | 3,210 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 36 |
| Overall Study | No drug administration | 3 |
| Overall Study | No visit after first day of treatment | 44 |
| Overall Study | Protocol Violation | 24 |
Baseline characteristics
| Characteristic | Selara |
|---|---|
| Age, Customized <65 years old | 1224 participants |
| Age, Customized >=65 years old | 1986 participants |
| Sex: Female, Male Female | 1539 Participants |
| Sex: Female, Male Male | 1671 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 59 / 3,210 |
| serious Total, serious adverse events | 16 / 3,210 |
Outcome results
Primary
Number of Participants With Serious Treatment Related Adverse Events.
Serious treatment related adverse events mean those that may lead to death, life-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder.
Time frame: 12 weeks
Population: No statistical analysis provided for the frequency of serious treatment related adverse events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Selara | Number of Participants With Serious Treatment Related Adverse Events. | 16 participants |
Primary
Number of Participants With Treatment Related Adverse Events.
Adverse events mean all unfavorable events that occur in participants after administration of Selara, irrespective of causal relationship to Selara (including clinically problematic abnormal changes in laboratory test values). Treatment Related Adverse Events were evaluated in company with the causal relationship to Selara.
Time frame: 12 weeks
Population: No statistical analysis provided for the frequency of Treatment Related adverse events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Selara | Number of Participants With Treatment Related Adverse Events. | 75 participants |
Secondary
Change in Diastolic Blood Pressure Over Time.
The primary analysis item was the mean diastolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely.
Time frame: 12 weeks
Population: The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Selara | Change in Diastolic Blood Pressure Over Time. | 85.1 mmHg | Standard Deviation 13.9 |
| At 4 Weeks | Change in Diastolic Blood Pressure Over Time. | 79.5 mmHg | Standard Deviation 12.9 |
| At 8 Weeks | Change in Diastolic Blood Pressure Over Time. | 78.0 mmHg | Standard Deviation 12.5 |
| At 12 Weeks | Change in Diastolic Blood Pressure Over Time. | 76.6 mmHg | Standard Deviation 11.8 |
| At Last Evaluation Date | Change in Diastolic Blood Pressure Over Time. | 77.0 mmHg | Standard Deviation 11.7 |
Comparison: The null hypothesis is that the mean diastolic blood pressure at 4 weeks does not differ from that at baseline.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis is that the mean diastolic blood pressure at 8 weeks does not differ from that at baseline.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis is that the mean diastolic blood pressure at 12 weeks does not differ from that at baseline.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis is that the mean diastolic blood pressure at last evaluation date does not differ from that at baseline.p-value: <0.001t-test, 1 sided
Secondary
Change in Systolic Blood Pressure Over Time.
The primary analysis item was the mean systolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely.
Time frame: 12 weeks
Population: The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Selara | Change in Systolic Blood Pressure Over Time. | 151.8 mmHg | Standard Deviation 19.6 |
| At 4 Weeks | Change in Systolic Blood Pressure Over Time. | 140.7 mmHg | Standard Deviation 17.7 |
| At 8 Weeks | Change in Systolic Blood Pressure Over Time. | 137.5 mmHg | Standard Deviation 16.2 |
| At 12 Weeks | Change in Systolic Blood Pressure Over Time. | 134.7 mmHg | Standard Deviation 15.6 |
| At Last Evaluation Date | Change in Systolic Blood Pressure Over Time. | 134.0 mmHg | Standard Deviation 15.9 |
Comparison: The null hypothesis is that the mean systolic blood pressure at 4 weeks does not differ from that at baseline.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis is that the mean systolic blood pressure at 8 weeks does not differ from that at baseline.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis is that the mean systolic blood pressure at 12 weeks does not differ from that at baseline.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis is that the mean systolic blood pressure at last evaluation date does not differ from that at baseline.p-value: <0.001t-test, 1 sided
Secondary
Number of Participants That Responded to Selara Treatment.
Number of participants among the efficacy analysis population that responded to Selara treatment.
Time frame: 12 weeks
Population: The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Selara | Number of Participants That Responded to Selara Treatment. | 2772 participants |