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Completed

NCT Number: NCT03342690

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

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

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Key information

Conditions

Chronic Heart Failure

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Local Country Office

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Eplerenone

Drug

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.

Other names: Selara

Primary outcomes

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

    Time frame: 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 outcomes

  1. Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants

    Time frame: 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.

  2. The Number of Deaths (Overall Deaths)

    Time frame: 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).

  3. The Number of Deaths (Cardiovascular Deaths)

    Time frame: 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).

  4. The Overall Mortality Rate

    Time frame: 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).

  5. The Cardiovascular-related Mortality Rate

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2017
Registry last updated
Jul 11, 2023

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.

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