Trial · NCT00232180
A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines
NCT00232180, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2011-06-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines. Trials, record NCT00232180. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00232180
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines
- NCT number
- NCT00232180
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,743 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Heart Failure
- Interventions
- Eplerenone
- First posted
- 2005-10-04
- Last updated
- 2020-12-22
- Results first posted
- 2011-06-27
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date | Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010) | CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. |
| Primary | Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated) | Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011) | CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. |
| Secondary | Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated) | Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011) | Death due to any cause or first of occurrence HF hospitalization. HF hospitalization is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. |
| Secondary | Number of Participants With First Occurrence of All-Cause Mortality (Adjudicated) | Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011) | Death due to any cause. |
| Secondary | Number of Participants With First Occurrence of Cardiovascular (CV) Mortality (Adjudicated) | Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011) | CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). |
| Secondary | Number of Participants With First Occurrence of All-Cause Hospitalization (Adjudicated) | Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011) | Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility). |
| Secondary | Number of Participants With First Occurrence of Heart Failure (HF) Hospitalization (Adjudicated) | Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011) | First occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. |
| Secondary | Number of Participants With First Occurrence of All-Cause Mortality or All-Cause Hospitalization (Adjudicated) | Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011) | Death due to any cause or hospitalization due to any cause. Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility). |
| Secondary | Number of Participants With First Occurrence Of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization (Adjudicated) | Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011) | Death due to HF or first occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. |
| Secondary | Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization (Adjudicated) | Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011) | First occurrence of CV hospitalization. CV hospitalization is defined as hospitalization due to HF (first or subsequent), acute myocardial infarction, angina pectoris (unstable), cardiac arrhythmia (atrial fibrillation \[AF\], atrial flutter, supraventricular arrhythmias, or ventricular arrhythmias), stroke/CVA, other CV reasons (such as hypotension or peripheral vascular disease), implantation of a cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) with CV event as the primary reason for hospitalization as determined by endpoint committee adjudicator. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date | Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010) | Full analysis set (FAS) using intent-to-treat (ITT) principle: All randomized participants, followed for mortality, other major endpoints for duration of double blind treatment period, regardless of compliance with study drug and protocol. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | participants | NUMBER |
| PRIMARY | Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated) | Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011) | FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. | participants | NUMBER |
| SECONDARY | Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated) | Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011) | FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here n signifies participants evaluated at that time point. | participants | NUMBER |
| SECONDARY | Number of Participants With First Occurrence of All-Cause Mortality (Adjudicated) | Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011) | FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here n signifies participants evaluated at that time point. | participants | NUMBER |
| SECONDARY | Number of Participants With First Occurrence of Cardiovascular (CV) Mortality (Adjudicated) | Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011) | FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here n signifies participants evaluated at that time point. | participants | NUMBER |
| SECONDARY | Number of Participants With First Occurrence of All-Cause Hospitalization (Adjudicated) | Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011) | FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here n signifies participants evaluated at that time point. | participants | NUMBER |
| SECONDARY | Number of Participants With First Occurrence of Heart Failure (HF) Hospitalization (Adjudicated) | Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011) | FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here n signifies participants evaluated at that time point. | participants | NUMBER |
| SECONDARY | Number of Participants With First Occurrence of All-Cause Mortality or All-Cause Hospitalization (Adjudicated) | Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011) | FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here n signifies participants evaluated at that time point. | participants | NUMBER |
| SECONDARY | Number of Participants With First Occurrence Of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization (Adjudicated) | Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011) | FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here n signifies participants evaluated at that time point. | participants | NUMBER |
| SECONDARY | Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization (Adjudicated) | Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011) | FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here n signifies participants evaluated at that time point. | participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date | Eplerenone: Double-blind Phase | 249 | participants | ||
| Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date | Placebo: Double-blind Phase | 356 | participants | ||
| Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated) | Eplerenone: Double-blind Phase | 288 | participants | ||
| Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated) | Placebo: Double-blind Phase | 392 | participants | ||
| Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated) | Eplerenone: Double-blind Phase | Up to 50 months (cut-off) (n= 1364, 1373) | 270 | participants | |
| Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated) | Placebo: Double-blind Phase | Up to 50 months (cut-off) (n= 1364, 1373) | 376 | participants | |
| Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated) | Eplerenone: Double-blind Phase | Up to 59.5 months (complete DB) (n= 1367, 1376) | 311 | participants | |
| Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated) | Placebo: Double-blind Phase | Up to 59.5 months (complete DB) (n= 1367, 1376) | 418 | participants | |
| Number of Participants With First Occurrence of All-Cause Mortality (Adjudicated) | Eplerenone: Double-blind Phase | Up to 50 months (cut-off) (n= 1364, 1373) | 171 | participants | |
| Number of Participants With First Occurrence of All-Cause Mortality (Adjudicated) | Placebo: Double-blind Phase | Up to 50 months (cut-off) (n= 1364, 1373) | 213 | participants |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind (DB) Phase | STARTED | Eplerenone: Double-blind Phase | 1,367 | |
| Double-blind (DB) Phase | STARTED | Placebo: Double-blind Phase | 1,376 | |
| Double-blind (DB) Phase | STARTED | Eplerenone: Open Label Phase | 0 | |
| Double-blind (DB) Phase | Treated | Eplerenone: Double-blind Phase | 1,364 | |
| Double-blind (DB) Phase | Treated | Placebo: Double-blind Phase | 1,372 | |
| Double-blind (DB) Phase | Treated | Eplerenone: Open Label Phase | 0 | |
| Double-blind (DB) Phase | COMPLETED | Eplerenone: Double-blind Phase | 826 | |
| Double-blind (DB) Phase | COMPLETED | Placebo: Double-blind Phase | 771 | |
| Double-blind (DB) Phase | COMPLETED | Eplerenone: Open Label Phase | 0 | |
| Double-blind (DB) Phase | NOT COMPLETED | Eplerenone: Double-blind Phase | 541 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events3,490
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 | Atrial fibrillation | Cardiac disorders | Eplerenone: Double-blind Phase (May 25, 2010 Data Cut-off) | 29 | 1,360 | |
| other | Atrial fibrillation | Cardiac disorders | Placebo: Double-blind Phase(May 25, 2010 Data Cutoff) | 36 | 1,369 | |
| other | Atrial fibrillation | Cardiac disorders | Eplerenone: Double-blind Phase | 37 | 1,364 | |
| other | Atrial fibrillation | Cardiac disorders | Placebo: Double-blind Phase | 42 | 1,372 | |
| other | Atrial fibrillation | Cardiac disorders | Eplerenone: Open Label Phase | 42 | 1,245 | |
| other | Cardiac failure | Cardiac disorders | Eplerenone: Double-blind Phase (May 25, 2010 Data Cut-off) | 69 | 1,360 | |
| other | Cardiac failure | Cardiac disorders | Placebo: Double-blind Phase(May 25, 2010 Data Cutoff) | 99 | 1,369 | |
| other | Cardiac failure | Cardiac disorders | Eplerenone: Double-blind Phase | 84 | 1,364 | |
| other | Cardiac failure | Cardiac disorders | Placebo: Double-blind Phase | 107 | 1,372 | |
| other | Cardiac failure | Cardiac disorders | Eplerenone: Open Label Phase | 29 | 1,245 |
1 to 10 of 3,490Source ClinicalTrials.gov
See all 3,490 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eplerenone: Double-blind Phase (May 25, 2010 Data Cut-off) | ||
| Total, all-cause mortality | Placebo: Double-blind Phase(May 25, 2010 Data Cutoff) | ||
| Total, all-cause mortality | Eplerenone: Double-blind Phase | ||
| Total, all-cause mortality | Placebo: Double-blind Phase | ||
| Total, all-cause mortality | Eplerenone: Open Label Phase | ||
| Total, other adverse events | Eplerenone: Double-blind Phase (May 25, 2010 Data Cut-off) | 547 | 1,360 |
| Total, other adverse events | Placebo: Double-blind Phase(May 25, 2010 Data Cutoff) | 540 | 1,369 |
| Total, other adverse events | Eplerenone: Double-blind Phase | 640 | 1,364 |
| Total, other adverse events | Placebo: Double-blind Phase | 617 | 1,372 |
| Total, other adverse events | Eplerenone: Open Label Phase | 329 | 1,245 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers15
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Eplerenone: Double-blind Phase vs Placebo: Double-blind Phase: Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated) | Trial comparisons |
Eplerenone: Double-blind Phase vs Placebo: Double-blind Phase: Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date | Trial comparisons |
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.
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