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

DRUG USE INVESTIGATION OF SELARA(REGISTERED). TABLETS(AN INVESTIGATION FOR CHRONIC HEART FAILURE)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03342690

Enrollment

1165

Registered

2017-11-17

Start date

2017-07-05

Completion date

2020-07-15

Last updated

2023-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

Keywords

Selara, Chronic Heart Failure

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.

Interventions

DRUGEplerenone

In adults, usually, administer the initial dose of 25 mg once daily according to the patient's serum potassium level and conditions, increase dosage up to 50 mg once daily after 4 week; patients with moderate renal impairment should start with 25 mg every other day and the maximum dosage should be 25 mg once daily. Also, dose should be reduced or interrupted according to serum potassium level and patient's conditions.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to No maximum

Healthy volunteers

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.

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.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment	52 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

Measure	Time frame	Description
Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants	52 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 (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 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).
The Overall Mortality Rate	52 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 Cardiovascular-related Mortality Rate	52 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).

Countries

Japan

Participant flow

Participants by arm

Arm	Count
Selara Tablets (Eplerenone) Participants who received Selara as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion.	1,139
Total	1,139

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Missing Information	9
Overall Study	Protocol Violation	16

Baseline characteristics

Characteristic	Selara Tablets (Eplerenone)	—
Age, Customized ≥15 and <65 years	219 Participants	—
Age, Customized <15 years	0 Participants	—
Age, Customized ≥65 years	920 Participants	—
Estimated creatinine clearance (eCLCr) <30 mL/min	92 Participants	—
Estimated creatinine clearance (eCLCr) ≥30 mL/min and <50 mL/min	316 Participants	—
Estimated creatinine clearance (eCLCr) ≥50 mL/min	524 Participants	—
Estimated creatinine clearance (eCLCr) Unknown	207 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	516 Participants	—
Sex: Female, Male Male	623 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	44 / 1,139
other Total, other adverse events	121 / 1,139
serious Total, serious adverse events	103 / 1,139

Outcome results

Primary

Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment

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.