Trial · NCT00092677
An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)
NCT00092677, Phase 3, Completed, Organon and Co; results first posted 2009-05-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED). Trials, record NCT00092677. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00092677
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)
- NCT number
- NCT00092677
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,873 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Aortic Stenosis
- Interventions
- ezetimibe (+) simvastatin, Comparator: Placebo
- First posted
- 2004-09-28
- Last updated
- 2024-05-16
- Results first posted
- 2009-05-27
- Limitations and caveats
It is important to note that several of the ischemic outcomes making up the composite ischemic endpoint can occur as a causal consequence of aortic stenosis progression itself, or in association with its standard treatment (aortic valve replacement).
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events) | Entire follow-up (median = 4.35 years) | Composite endpoint of MCE consists of cardiovascular death, AVR (aortic valve replacement) surgery, CHF(congestive heart failure) as a result of progression of aortic stenosis, nonfatal MI (myocardial infarction), CABG (coronary artery bypass) surgery, PCI (percutaneous coronary intervention), hospitalized unstable angina, and nonhemorrhagic stroke |
| Secondary | Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of AVE (Aortic Valve Events) | Entire follow-up (median = 4.35 years) | Composite endpoint of AVE (aortic valve events) consists of AVR surgery, CHF (as a result of progression of AS), or cardiovascular death |
| Secondary | Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of ICE (Ischemic Cardiovascular Events) | Entire follow-up (median = 4.35 years) | Composite endpoint of ICE (ischemic cardiovascular events) consists of cardiovascular death, nonfatal MI, CABG, PCI, hospitalized unstable angina, and nonhemorrhagic stroke |
| Secondary | Change From Baseline in Peak Transaortic Jet Velocity | Baseline to End of follow-up (median = 4.35 years) or pre-aortic valve replacement | Mean change from baseline in peak transaortic jet velocity |
| Other | Cardiovascular Death | Entire follow-up (median = 4.35 years) | Number of participants that experienced cardiovascular death |
| Other | Aortic Valve Replacement (AVR) | Entire follow-up (median = 4.35 years) | Number of participants that experienced aortic valve replacement (AVR) |
| Other | Congestive Heart Failure (CHF) Due to Progression of Aortic Stenosis (AS) | Entire follow-up (median = 4.35 years) | Number of participants that experienced Congestive Heart Failure (CHF) due to progression of aortic stenosis (AS) |
| Other | Nonfatal Myocardial Infarction (MI) | Entire follow-up (median = 4.35 years) | Number of participants that experienced nonfatal myocardial infarction (MI) |
| Other | Coronary Artery Bypass Grafting (CABG) | Entire follow-up (median = 4.35 years) | Number of participants that experienced coronary artery bypass grafting (CABG) |
| Other | Percutaneous Coronary Intervention (PCI) | Entire follow-up (median = 4.35 years) | Number of participants that experienced percutaneous coronary intervention (PCI) |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events) | Entire follow-up (median = 4.35 years) | Intention-to-Treat | Participants | NUMBER |
| SECONDARY | Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of AVE (Aortic Valve Events) | Entire follow-up (median = 4.35 years) | Intention-to-Treat | Participants | NUMBER |
| SECONDARY | Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of ICE (Ischemic Cardiovascular Events) | Entire follow-up (median = 4.35 years) | Intention-to-Treat | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Cardiovascular Death | Entire follow-up (median = 4.35 years) | Intention-to-Treat | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Aortic Valve Replacement (AVR) | Entire follow-up (median = 4.35 years) | Intention-to-Treat | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Congestive Heart Failure (CHF) Due to Progression of Aortic Stenosis (AS) | Entire follow-up (median = 4.35 years) | Intention-to-Treat | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Nonfatal Myocardial Infarction (MI) | Entire follow-up (median = 4.35 years) | Intention-to-Treat | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Coronary Artery Bypass Grafting (CABG) | Entire follow-up (median = 4.35 years) | Intention-to-Treat | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percutaneous Coronary Intervention (PCI) | Entire follow-up (median = 4.35 years) | Intention-to-Treat | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Hospitalization for Unstable Angina | Entire follow-up (median = 4.35 years) | Intention-to-Treat | Participants | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events) | EZ/Simva 10/40 mg | 333 | Participants | ||
| Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events) | Placebo | 355 | Participants | ||
| Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of AVE (Aortic Valve Events) | EZ/Simva 10/40 mg | 308 | Participants | ||
| Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of AVE (Aortic Valve Events) | Placebo | 326 | Participants | ||
| Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of ICE (Ischemic Cardiovascular Events) | EZ/Simva 10/40 mg | 148 | Participants | ||
| Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of ICE (Ischemic Cardiovascular Events) | Placebo | 187 | Participants | ||
| Cardiovascular Death | EZ/Simva 10/40 mg | 47 | Participants | ||
| Cardiovascular Death | Placebo | 56 | Participants | ||
| Aortic Valve Replacement (AVR) | EZ/Simva 10/40 mg | 267 | Participants | ||
| Aortic Valve Replacement (AVR) | Placebo | 278 | Participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EZ/Simva 10/40 mg | 944 | |
| Overall Study | STARTED | Placebo | 929 | |
| Overall Study | COMPLETED | EZ/Simva 10/40 mg | 939 | |
| Overall Study | COMPLETED | Placebo | 918 | |
| Overall Study | NOT COMPLETED | EZ/Simva 10/40 mg | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 11 |
Source ClinicalTrials.gov
Adverse events1,230
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 | EZ/Simva 10/40 mg | 50 | 943 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 33 | 929 | |
| other | Angina pectoris | Cardiac disorders | EZ/Simva 10/40 mg | 36 | 943 | |
| other | Angina pectoris | Cardiac disorders | Placebo | 44 | 929 | |
| other | Aortic valve stenosis | Cardiac disorders | EZ/Simva 10/40 mg | 139 | 943 | |
| other | Aortic valve stenosis | Cardiac disorders | Placebo | 177 | 929 | |
| other | Atrial fibrillation | Cardiac disorders | EZ/Simva 10/40 mg | 88 | 943 | |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 113 | 929 | |
| other | Atrioventricular block first degree | Cardiac disorders | EZ/Simva 10/40 mg | 23 | 943 | |
| other | Atrioventricular block first degree | Cardiac disorders | Placebo | 11 | 929 |
1 to 10 of 1,230Source ClinicalTrials.gov
See all 1,230 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EZ/Simva 10/40 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | EZ/Simva 10/40 mg | 703 | |
| Total, other adverse events | Placebo | 706 | |
| Total, serious adverse events | EZ/Simva 10/40 mg | 471 | |
| Total, serious adverse events | Placebo | 465 |
Source ClinicalTrials.gov
Papers35
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 comparisons14
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| EZ/Simva 10/40 mg vs Placebo: Incident Cancer | Trial comparisons |
| EZ/Simva 10/40 mg vs Placebo: Hospitalization for Unstable Angina | Trial comparisons |
| EZ/Simva 10/40 mg vs Placebo: Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events) | Trial comparisons |
| EZ/Simva 10/40 mg vs Placebo: Death (Any Cause) | Trial comparisons |
| EZ/Simva 10/40 mg vs Placebo: Percutaneous Coronary Intervention (PCI) | Trial comparisons |
| EZ/Simva 10/40 mg vs Placebo: Coronary Artery Bypass Grafting (CABG) | Trial comparisons |
| EZ/Simva 10/40 mg vs Placebo: Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of ICE (Ischemic Cardiovascular Events) | Trial comparisons |
| EZ/Simva 10/40 mg vs Placebo: Death Due to Cancer | Trial comparisons |
| EZ/Simva 10/40 mg vs Placebo: Aortic Valve Replacement (AVR) | Trial comparisons |
| EZ/Simva 10/40 mg vs Placebo: Nonfatal Myocardial Infarction (MI) | Trial comparisons |
1 to 10 of 14
See all 14 trial comparisonsTests0
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/NCT00092677
GET https://conductscience.org/api/trials/v1/NCT00092677/results?page=2