Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan) (ESSENCE)

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Selara

• Study Type: Observational
• Enrollment (Actual): 3338

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients whom an investigator involving A6141113 prescribes the Selara tablet.

Description

Inclusion Criteria:

• Male or Female patients who are prescribed Selara tablet for Hypertension.

Exclusion Criteria:

• Subjects who have been prescribed Selara tablet.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Eplerenone; Subjects who are treated with Eplerenone tablet for hypertension disease	Drug: Selara; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 5, 2008
• First Submitted That Met QC Criteria: September 5, 2008
• First Posted (Estimate): September 9, 2008

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 19, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Hypertension; Eplerenone; Regulatory Post Marketing Commitment Plan; Selara; Good post-marketing study Practice; Drug use Investigation; ESSENCE
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: A6141113