N/A
Completed N=1,164
Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure)
Source: ClinicalTrials.gov NCT03342690 ↗Enrolled (actual)
1,164
Serious AEs
9.0%
Results posted
Jun 2021
Primary outcomePrimary: Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment — 9.49; 1.58 Percentage of Participants
Summary
Secondary Data Collection Study; Safety And Effectiveness Of Selara Under Japanese Medical Practice
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment |
9.49; 1.58 | — |
| SECONDARY Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants |
5.97; 0.79 | — |
| SECONDARY The Number of Deaths (Overall Deaths) |
44 | — |
| SECONDARY The Number of Deaths (Cardiovascular Deaths) |
15 | — |
| SECONDARY The Overall Mortality Rate |
4.4 | — |
| SECONDARY The Cardiovascular-related Mortality Rate |
1.5 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03342690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.