Trial · NCT00862251
Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)
NCT00862251, Phase 3, Completed, Organon and Co; results first posted 2012-03-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED). Trials, record NCT00862251. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00862251
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)
- NCT number
- NCT00862251
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 808 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Cardiovascular Disorder, Diabetes Mellitus
- Interventions
- ezetimibe (+) simvastatin, simvastatin 40 mg or atorvastatin 20 mg, Rosuvastatin, atorvastatin 10 mg or simvastatin 20 mg
- First posted
- 2009-03-16
- Last updated
- 2024-05-16
- Results first posted
- 2012-03-16
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin). | Baseline and Week 6 | |
| Secondary | In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin | Baseline and Week 6 | |
| Secondary | In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin | Baseline and Week 6 | |
| Secondary | Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin | Baseline and Week 6 | |
| Secondary | Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) | Week 6 | |
| Secondary | In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) | Week 6 | |
| Secondary | In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) | Week 6 | |
| Secondary | Percent Change From Baseline in Total Cholesterol (TC) | Baseline and Week 6 | |
| Secondary | Percent Change From Baseline in Triglycerides | Baseline and Week 6 | |
| Secondary | Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | Baseline and Week 6 |
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 | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin). | Baseline and Week 6 | Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin | Baseline and Week 6 | Analysis performed on subpopulation of participants who were previously treated with simvastatin 20 mg and were switched to either Ezetimibe/simvastatin or had simvastatin dose doubled to 40 mg | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin | Baseline and Week 6 | Analysis performed on subpopulation of participants who were previously treated with atorvastatin 10 mg and were switched to either Ezetimibe/simvastatin or had atorvastatin dose doubled to 20 mg | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin | Baseline and Week 6 | Efficacy data were analyzed primarily based upon the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) | Week 6 | Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | participants | NUMBER |
| SECONDARY | In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) | Week 6 | Analysis performed on subpopulation of participants who were previously treated with simvastatin 20 mg and were switched to either Ezetimibe/simvastatin or had simvastatin dose doubled to 40 mg | participants | NUMBER |
| SECONDARY | In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) | Week 6 | Analysis performed on subpopulation of participants who were previously treated with atorvastatin 10 mg and were switched to either Ezetimibe/simvastatin or had atorvastatin dose doubled to 20 mg | participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Total Cholesterol (TC) | Baseline and Week 6 | Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Triglycerides | Baseline and Week 6 | Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | Baseline and Week 6 | Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | percent change | LEAST_SQUARES_MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin). | Ezetimibe/Simvastatin | -23.13 | 95% Confidence Interval -25.95 to -20.31 | Percent change | |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin). | Doubling Statin Dose | -8.37 | 95% Confidence Interval -12.32 to -4.41 | Percent change | |
| In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin | Ezetimibe/Simvastatin | -21.59 | 95% Confidence Interval -25.54 to -17.65 | Percent change | |
| In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin | Doubling Simvastatin Dose | -7.98 | 95% Confidence Interval -13.57 to -2.38 | Percent change | |
| In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin | Ezetimibe/Simvastatin | -24.58 | 95% Confidence Interval -28.63 to -20.53 | Percent change | |
| In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin | Doubling Atorvastatin Dose | -8.85 | 95% Confidence Interval -14.47 to -3.23 | Percent change | |
| Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin | Ezetimibe/Simvastatin | -23.13 | 95% Confidence Interval -25.95 to -20.31 | Percent change | |
| Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin | Rosuvastatin | -19.32 | 95% Confidence Interval -22.14 to -16.51 | Percent change | |
| Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) | Ezetimibe/Simvastatin | 171 | participants | ||
| Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) | Doubling Statin Dose | 43 | participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ezetimibe/Simvastatin | 322 | |
| Overall Study | STARTED | Doubling Statin Dose | 162 | |
| Overall Study | STARTED | Rosuvastatin | 324 | |
| Overall Study | COMPLETED | Ezetimibe/Simvastatin | 303 | |
| Overall Study | COMPLETED | Doubling Statin Dose | 157 | |
| Overall Study | COMPLETED | Rosuvastatin | 315 | |
| Overall Study | NOT COMPLETED | Ezetimibe/Simvastatin | 19 | |
| Overall Study | NOT COMPLETED | Doubling Statin Dose | 5 | |
| Overall Study | NOT COMPLETED | Rosuvastatin | 9 |
Source ClinicalTrials.gov
Adverse events15
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 |
|---|---|---|---|---|---|---|
| serious | Angina pectoris | Cardiac disorders | Ezetimibe/Simvastatin | 1 | 321 | 1 |
| serious | Angina pectoris | Cardiac disorders | Doubling Statin Dose | 0 | 162 | 0 |
| serious | Angina pectoris | Cardiac disorders | Rosuvastatin | 0 | 323 | 0 |
| serious | Angina unstable | Cardiac disorders | Ezetimibe/Simvastatin | 0 | 321 | 0 |
| serious | Angina unstable | Cardiac disorders | Doubling Statin Dose | 0 | 162 | 0 |
| serious | Angina unstable | Cardiac disorders | Rosuvastatin | 1 | 323 | 1 |
| serious | Coronary artery disease | Cardiac disorders | Ezetimibe/Simvastatin | 1 | 321 | 1 |
| serious | Coronary artery disease | Cardiac disorders | Doubling Statin Dose | 0 | 162 | 0 |
| serious | Coronary artery disease | Cardiac disorders | Rosuvastatin | 0 | 323 | 0 |
| serious | Myocardial infarction | Cardiac disorders | Ezetimibe/Simvastatin | 0 | 321 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ezetimibe/Simvastatin | ||
| Total, all-cause mortality | Doubling Statin Dose | ||
| Total, all-cause mortality | Rosuvastatin | ||
| Total, other adverse events | Ezetimibe/Simvastatin | 0 | 321 |
| Total, other adverse events | Doubling Statin Dose | 0 | 162 |
| Total, other adverse events | Rosuvastatin | 0 | 323 |
| Total, serious adverse events | Ezetimibe/Simvastatin | 2 | 321 |
| Total, serious adverse events | Doubling Statin Dose | 1 | 162 |
| Total, serious adverse events | Rosuvastatin | 2 | 323 |
Source ClinicalTrials.gov
Papers4
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 |
|---|---|
Ezetimibe/Simvastatin vs Doubling Simvastatin Dose: In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) | Trial comparisons |
Ezetimibe/Simvastatin vs Doubling Atorvastatin Dose: In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) | 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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