Trial · NCT03342690
Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure)
NCT03342690, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2021-06-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure). Trials, record NCT03342690. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03342690
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure)
- NCT number
- NCT03342690
- Status
- Completed
- Enrollment
- 1,165 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Chronic Heart Failure
- Interventions
- Eplerenone
- First posted
- 2017-11-17
- Last updated
- 2023-07-11
- Results first posted
- 2021-06-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment | 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 | Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants | 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. |
| Secondary | The Number of Deaths (Overall Deaths) | 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). |
| Secondary | The Number of Deaths (Cardiovascular Deaths) | 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). |
| Secondary | The Overall Mortality Rate | 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). |
| Secondary | The Cardiovascular-related Mortality Rate | 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). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment | 52 weeks from the start date | The safety analysis set comprised of chronic heart failure participants who satisfied the inclusion criteria and had received Selara at least once. Of the participants included in the safety analysis set (n=1139), 316 participants had moderate renal impairment (≥30 mL/min and \<50 mL/min in eCLCr). | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants | 52 weeks from the start date | The safety analysis set comprised of chronic heart failure participants who satisfied the inclusion criteria and had received Selara at least once. | Percentage of Participants | NUMBER |
| SECONDARY | The Number of Deaths (Overall Deaths) | 52 weeks from the start date | The efficacy analysis set comprised of chronic heart failure participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. | Participants | NUMBER |
| SECONDARY | The Number of Deaths (Cardiovascular Deaths) | 52 weeks from the start date | The efficacy analysis set comprised of chronic heart failure participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. | Participants | NUMBER |
| SECONDARY | The Overall Mortality Rate | 52 weeks from the start date | The efficacy analysis set comprised of chronic heart failure participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. | events per 100 patient-year | NUMBER |
| SECONDARY | The Cardiovascular-related Mortality Rate | 52 weeks from the start date | The efficacy analysis set comprised of chronic heart failure participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. | events per 100 patient-year | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment | Selara Tablets (Eplerenone) | ADR | 9.49 | Percentage of Participants | |
| Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment | Selara Tablets (Eplerenone) | Serious ADR | 1.58 | Percentage of Participants | |
| Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants | Selara Tablets (Eplerenone) | ADR | 5.97 | Percentage of Participants | |
| Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants | Selara Tablets (Eplerenone) | Serious ADR | 0.79 | Percentage of Participants | |
| The Number of Deaths (Overall Deaths) | Selara Tablets (Eplerenone) | 44 | Participants | ||
| The Number of Deaths (Cardiovascular Deaths) | Selara Tablets (Eplerenone) | 15 | Participants | ||
| The Overall Mortality Rate | Selara Tablets (Eplerenone) | 4.4 | 95% Confidence Interval 3.2 to 6.0 | events per 100 patient-year | |
| The Cardiovascular-related Mortality Rate | Selara Tablets (Eplerenone) | 1.5 | 95% Confidence Interval 0.8 to 2.5 | events per 100 patient-year |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Selara Tablets (Eplerenone) | 1,164 | |
| Overall Study | COMPLETED | Selara Tablets (Eplerenone) | 1,139 | |
| Overall Study | NOT COMPLETED | Selara Tablets (Eplerenone) | 25 |
Source ClinicalTrials.gov
Adverse events149
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Selara Tablets (Eplerenone) | 3 | 1,139 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Selara Tablets (Eplerenone) | 1 | 1,139 | |
| other | Atrial fibrillation | Cardiac disorders | Selara Tablets (Eplerenone) | 2 | 1,139 | |
| other | Bradycardia | Cardiac disorders | Selara Tablets (Eplerenone) | 1 | 1,139 | |
| other | Cardiac failure | Cardiac disorders | Selara Tablets (Eplerenone) | 4 | 1,139 | |
| other | Palpitations | Cardiac disorders | Selara Tablets (Eplerenone) | 1 | 1,139 | |
| other | Vertigo | Ear and labyrinth disorders | Selara Tablets (Eplerenone) | 1 | 1,139 | |
| other | Constipation | Gastrointestinal disorders | Selara Tablets (Eplerenone) | 2 | 1,139 | |
| other | Diarrhoea | Gastrointestinal disorders | Selara Tablets (Eplerenone) | 1 | 1,139 | |
| other | Dysphagia | Gastrointestinal disorders | Selara Tablets (Eplerenone) | 1 | 1,139 |
1 to 10 of 149Source ClinicalTrials.gov
See all 149 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Selara Tablets (Eplerenone) | 44 | 1,139 |
| Total, other adverse events | Selara Tablets (Eplerenone) | 121 | 1,139 |
| Total, serious adverse events | Selara Tablets (Eplerenone) | 103 | 1,139 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03342690
GET https://conductscience.org/api/trials/v1/NCT03342690/events?page=2