Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Study Overview
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Brief Summary
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To collect the efficacy and safety information of Eplerenone on patients with hypertension related to their appropriate use in daily practice.

Official Title
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Eplerenone Observational Study Of Safety And Efficacy Evaluation To Normalize Blood Pressure For Clinical Effectiveness

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Selara


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female patients who are prescribed Selara tablet for Hypertension. Exclusion Criteria: Subjects who have been prescribed Selara tablet.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eplerenone<br>Subjects who are treated with Eplerenone tablet for hypertension disease | Drug: Selara<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| 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. | 12 weeks | 
| Number of Participants That Responded to Selara Treatment. | Number of participants among the efficacy analysis population that responded to Selara treatment. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eplerenone, Selara, Hypertension, Good post-marketing study Practice, Drug use Investigation, Regulatory Post Marketing Commitment Plan, ESSENCE