Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Subjects who have been prescribed Selara tablet.

Treatment and study plan

Selara

Drug

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.

Primary outcomes

Number of Participants With Treatment Related Adverse Events.

Time frame: 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.

Time frame: 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 outcomes

Change in Systolic Blood Pressure Over Time.

Time frame: 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.

Time frame: 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.

Time frame: 12 weeks

Number of participants among the efficacy analysis population that responded to Selara treatment.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Acronym: ESSENCE

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Sep 9, 2008
Registry last updated: Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed