Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03342690
Other study ID # A6141122
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03597646 - The Effect of Kinesio Taping on Pulmonary Function and Functional Capacity in Patients With Chronic Heart Failure N/A
Terminated NCT04065997 - Apogee International
Withdrawn NCT03675113 - Effect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure N/A
Completed NCT02916160 - Sacubitril-valsartan and Heart Failure Patients : the ENTRESTO-SAS Study Phase 4
Completed NCT03126656 - Effects of Testosterone on Myocardial Repolarization Phase 4
Completed NCT02268500 - VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT) Phase 4
Completed NCT02247245 - The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients. N/A
Terminated NCT01906957 - Cognition and Exercise Training N/A
Completed NCT01919918 - Muscle Afferent Feedback Effects in Patients With Heart Failure Phase 1
Not yet recruiting NCT01669395 - Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial N/A
Completed NCT00984529 - Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia N/A
Recruiting NCT00863421 - Sleep Disordered Breathing in Patients With Chronic Heart Failure N/A
Completed NCT02840565 - Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453 Phase 1
Completed NCT02441218 - Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study Phase 3
Completed NCT00149409 - Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure Phase 2/Phase 3
Terminated NCT05532046 - A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT) Phase 1
Recruiting NCT04984928 - Readmission Risk of Patients With Heart Failure.
Completed NCT02814097 - A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction Phase 2
Active, not recruiting NCT05560737 - ODYSSEE-vCHAT Mental Health Program for Heart Failure and Kidney Disease Patients
Recruiting NCT03286127 - Palliative Outcome Evaluation Muenster I