An observational study in Chronic Heart Failure, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 1 site in Japan. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2023-07-11.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (part of Viatris Inc.) · Observational
Secondary Data Collection Study; Safety And Effectiveness Of Selara Under Japanese Medical Practice
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 1,165 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 434 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
First submitted before Pfizer's Upjohn has merged with Mylan to form Viatris Inc. became part of Viatris Inc..
Counted across the registry records on this site, refreshed daily.
The patients who meet the inclusion criteria and who were registered to this study within 14 days including the start date of treatment with this product will be subjects for this study
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with CHF receiving Selara (eplerenone)
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.
Also known as: Selara
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.
Time frame: 52 weeks from the start date
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.
Time frame: 52 weeks from the start date
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).
Time frame: 52 weeks from the start date
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).
Time frame: 52 weeks from the start date
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).
Time frame: 52 weeks from the start date
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).
Time frame: 52 weeks from the start date
| Milestone | Selara Tablets (Eplerenone) |
|---|---|
| Started | 1164 |
| Completed | 1139 |
| Not completed | 25 |
| Withdrew: Missing information | 9 |
| Withdrew: Protocol violation | 16 |
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.
| Percentage of Participants | Selara Tablets (Eplerenone) |
|---|---|
| ADR | 9.49 |
| Serious ADR | 1.58 |
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.
| Percentage of Participants | Selara Tablets (Eplerenone) |
|---|---|
| ADR | 5.97 |
| Serious ADR | 0.79 |
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).
| Participants | Selara Tablets (Eplerenone) |
|---|---|
| The Number of Deaths (Overall Deaths) | 44 |
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).
| Participants | Selara Tablets (Eplerenone) |
|---|---|
| The Number of Deaths (Cardiovascular Deaths) | 15 |
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).
| events per 100 patient-year | Selara Tablets (Eplerenone) |
|---|---|
| The Overall Mortality Rate | 4.4 (3.2 to 6.0) |
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).
| events per 100 patient-year | Selara Tablets (Eplerenone) |
|---|---|
| The Cardiovascular-related Mortality Rate | 1.5 (0.8 to 2.5) |
Collected over 52 weeks from the start date. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Selara Tablets (Eplerenone) | 44/1,139 (3.9%) | 103/1,139 (9%) | 121/1,139 (10.6%) |
| Event | Selara Tablets (Eplerenone) |
|---|---|
| Cardiac failureCardiac disorders | 15/1139 |
| PneumoniaInfections and infestations | 8/1139 |
| Cardiac failure acuteCardiac disorders | 7/1139 |
| Cardiac failure chronicCardiac disorders | 6/1139 |
| Cardiac failure congestiveCardiac disorders | 5/1139 |
| Cerebral infarctionNervous system disorders | 4/1139 |
| Ventricular fibrillationCardiac disorders | 3/1139 |
| Sinus node dysfunctionCardiac disorders | 3/1139 |
| HyperkalaemiaMetabolism and nutrition disorders | 3/1139 |
| DehydrationMetabolism and nutrition disorders | 3/1139 |
| Event | Selara Tablets (Eplerenone) |
|---|---|
| Renal impairmentRenal and urinary disorders | 24/1139 |
| HyperkalaemiaMetabolism and nutrition disorders | 16/1139 |
| HypotensionVascular disorders | 10/1139 |
| Blood pressure decreasedInvestigations | 9/1139 |
| DehydrationMetabolism and nutrition disorders | 5/1139 |
| Cardiac failureCardiac disorders | 4/1139 |
| Blood potassium increasedInvestigations | 4/1139 |
| AnaemiaBlood and lymphatic system disorders | 3/1139 |
| OedemaGeneral disorders | 3/1139 |
| HypokalaemiaMetabolism and nutrition disorders | 3/1139 |
A total of 1165 participants were enrolled in this study. Of the 1164 participants who completed the study, 25 participants were excluded from the safety analysis set due to the following reasons: protocol violation (16 participants), and no adverse event information (no visit after first day of treatment or unknown) (9 participants).
| Age, Customized(Participants) | Selara Tablets (Eplerenone) |
|---|---|
| <15 years | 0 |
| ≥15 and <65 years | 219 |
| ≥65 years | 920 |
| Sex: Female, Male(Participants) | Selara Tablets (Eplerenone) |
|---|---|
| Female | 516 |
| Male | 623 |
| Race and Ethnicity Not Collected(Participants) | Selara Tablets (Eplerenone) |
|---|
| Estimated creatinine clearance (eCLCr)(Participants) | Selara Tablets (Eplerenone) |
|---|---|
| <30 mL/min | 92 |
| ≥30 mL/min and <50 mL/min | 316 |
| ≥50 mL/min | 524 |
| Unknown | 207 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc. →