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Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure)

Completed
Conditions
Chronic Heart Failure
Interventions
Registration Number
NCT03342690
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Brief Summary

Secondary Data Collection Study; Safety And Effectiveness Of Selara Under Japanese Medical Practice

Detailed Description

This study will be conducted under the central registration system until the number of subjects who meet the conditions for registration reaches the target number of subjects. The patients will be observed up until Week 52.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1165
Inclusion Criteria
  • Patients in whom treatment with this drug is for CHF. The indications at approval for this drug are as follows. When using this drug, refer to the latest package insert of this drug.
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Exclusion Criteria
  • Patients who were previously registered for this study. Patients who received eplerenone within the past three months regardless of the reason for use.
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
EplerenoneEplerenonePatients with CHF receiving Selara (eplerenone)
Primary Outcome Measures
NameTimeMethod
Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment52 weeks from the start date

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Selara in a chronic heart failure participant with moderate renal impairment (≥30 mL/min and \<50 mL/min in eCLCr) who received Selara. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Selara was assessed by the physician.

Secondary Outcome Measures
NameTimeMethod
The Overall Mortality Rate52 weeks from the start date

The overall mortality rate was calculated by the incidence of all-cause death per observation time based on the person-year method (the number of deaths in 100 person-year).

The Number of Deaths (Overall Deaths)52 weeks from the start date

Overall deaths were described with the number of deaths from any cause at the time of 52 weeks after the start of administration, regardless of the treatment status (completed or discontinued).

The Cardiovascular-related Mortality Rate52 weeks from the start date

The cardiovascular-related mortality rate was calculated by the incidence of cardiovascular-related death per observation time based on the person-year method (the number of deaths in 100 person-year).

Cardiovascular deaths were defined as any death due to cardiac failure, myocardial infarction, arrhythmia (atrial fibrillation, atrial flutter, arrhythmia supraventricular, or ventricular arrhythmia), stroke or cerebrovascular attack, and other causes related to cardiovascular system at the time of 52 weeks after the start of administration, regardless of the treatment status (completed or discontinued).

Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants52 weeks from the start date

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Selara in a chronic heart failure participant who received Selara. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Selara was assessed by the physician.

The Number of Deaths (Cardiovascular Deaths)52 weeks from the start date

Cardiovascular deaths were described with the number of deaths defined as any death due to cardiac failure, myocardial infarction, arrhythmia (atrial fibrillation, atrial flutter, arrhythmia supraventricular, or ventricular arrhythmia), stroke or cerebrovascular attack, and other causes related to cardiovascular system at the time of 52 weeks after the start of administration, regardless of the treatment status (completed or discontinued).

Trial Locations

Locations (1)

Pfizer Local Country Office

🇯🇵

Tokyo, Japan

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