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

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03342690
• Other study ID #: A6141122
• Status: Completed
• Start date: July 5, 2017
• Est. completion date: July 15, 2020

Study information

• Verified date: June 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 1165
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• Eplerenone
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.

Locations

Country	Name	City	State
Japan	Pfizer Local Country Office	Tokyo

Sponsors (1)

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

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	52 weeks from the start date
Secondary	Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants	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.	52 weeks from the start date
Secondary	The Number of Deaths (Overall Deaths)	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).	52 weeks from the start date
Secondary	The Number of Deaths (Cardiovascular Deaths)	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).	52 weeks from the start date
Secondary	The Overall Mortality Rate	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).	52 weeks from the start date
Secondary	The Cardiovascular-related Mortality Rate	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).	52 weeks from the start date

External Links

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