Trial · NCT00535405
A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)
NCT00535405, Phase 3, Completed, Organon and Co; results first posted 2010-05-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128). Trials, record NCT00535405. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00535405
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)
- NCT number
- NCT00535405
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,289 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Hypercholesterolemia
- Interventions
- Atorvastatin 10 mg, Ezetimibe 10 mg/simvastatin 20 mg, Atorvastatin 20 mg, Ezetimibe 10 mg/simvastatin 40 mg, Atorvastatin 40 mg
- First posted
- 2007-09-26
- Last updated
- 2024-05-16
- Results first posted
- 2010-05-25
Source ClinicalTrials.gov
Registered outcomes6
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 (LDL-C) at Week 12 | Baseline and 12 weeks | |
| Secondary | Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12 | 12 weeks | |
| Secondary | Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12 | 12 Weeks | Patients with AVD Who Achieved LDL-C \<70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia. |
| Secondary | Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12 | 12 Weeks | |
| Secondary | Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12 | 12 Weeks | Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring. |
| Secondary | Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12 | 12 Weeks | Patients with AVD Who Achieved LDL-C \<70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia. |
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 | Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 | Baseline and 12 weeks | Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Percent change in LDL-C | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12 | 12 weeks | Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Percent of Patients | MEAN |
| SECONDARY | Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12 | 12 Weeks | Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Percent of Patients | MEAN |
| SECONDARY | Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12 | 12 Weeks | Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Percent of Patients | MEAN |
| SECONDARY | Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12 | 12 Weeks | Patients with High Risk for CHD in the Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Percent of Patients | MEAN |
| SECONDARY | Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12 | 12 Weeks | Patients with AVD in the Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Percent of Patients | MEAN |
Source ClinicalTrials.gov
Results by group30
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 (LDL-C) at Week 12 | Atorvastatin 10 mg | -39.5 | 95% Confidence Interval -41.4 to -37.5 | Percent change in LDL-C | |
| Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 | Ezetimibe 10 mg/Simvastatin 20 mg | -54.2 | 95% Confidence Interval -56.1 to -52.2 | Percent change in LDL-C | |
| Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 | Atorvastatin 20 mg | -46.6 | 95% Confidence Interval -48.6 to -44.7 | Percent change in LDL-C | |
| Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 | Ezetimibe 10 mg/Simvastatin 40 mg | -59.1 | 95% Confidence Interval -61.0 to -57.1 | Percent change in LDL-C | |
| Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 | Atorva 40 mg | -50.8 | 95% Confidence Interval -52.8 to -48.9 | Percent change in LDL-C | |
| Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12 | Atorvastatin 10 mg | 9.9 | Standard Error 1.92 | Percent of Patients | |
| Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12 | Ezetimibe 10 mg/Simvastatin 20 mg | 51.3 | Standard Error 3.28 | Percent of Patients | |
| Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12 | Atorvastatin 20 mg | 26.1 | Standard Error 2.85 | Percent of Patients | |
| Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12 | Ezetimibe 10 mg/Simvastatin 40 mg | 68.2 | Standard Error 3.03 | Percent of Patients | |
| Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12 | Atorva 40 mg | 38.1 | Standard Error 3.14 | Percent of Patients |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atorvastatin 10 mg | 257 | |
| Overall Study | STARTED | Ezetimibe 10 mg/Simvastatin 20 mg | 259 | |
| Overall Study | STARTED | Atorvastatin 20 mg | 259 | |
| Overall Study | STARTED | Ezetimibe 10 mg/Simvastatin 40 mg | 257 | |
| Overall Study | STARTED | Atorva 40 mg | 257 | |
| Overall Study | COMPLETED | Atorvastatin 10 mg | 240 | |
| Overall Study | COMPLETED | Ezetimibe 10 mg/Simvastatin 20 mg | 233 | |
| Overall Study | COMPLETED | Atorvastatin 20 mg | 241 | |
| Overall Study | COMPLETED | Ezetimibe 10 mg/Simvastatin 40 mg | 235 | |
| Overall Study | COMPLETED | Atorva 40 mg | 241 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events190
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 | Constipation | Gastrointestinal disorders | Atorvastatin 10 mg | 3 | 257 | |
| other | Constipation | Gastrointestinal disorders | Ezetimibe 10 mg/Simvastatin 20 mg | 0 | 256 | |
| other | Constipation | Gastrointestinal disorders | Atorvastatin 20 mg | 0 | 258 | |
| other | Constipation | Gastrointestinal disorders | Ezetimibe 10 mg/Simvastatin 40 mg | 4 | 257 | |
| other | Constipation | Gastrointestinal disorders | Atorvastatin 40 mg | 5 | 256 | |
| other | Diarrhoea | Gastrointestinal disorders | Atorvastatin 10 mg | 3 | 257 | |
| other | Diarrhoea | Gastrointestinal disorders | Ezetimibe 10 mg/Simvastatin 20 mg | 1 | 256 | |
| other | Diarrhoea | Gastrointestinal disorders | Atorvastatin 20 mg | 1 | 258 | |
| other | Diarrhoea | Gastrointestinal disorders | Ezetimibe 10 mg/Simvastatin 40 mg | 4 | 257 | |
| other | Diarrhoea | Gastrointestinal disorders | Atorvastatin 40 mg | 3 | 256 |
1 to 10 of 190Source ClinicalTrials.gov
See all 190 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atorvastatin 10 mg | ||
| Total, all-cause mortality | Ezetimibe 10 mg/Simvastatin 20 mg | ||
| Total, all-cause mortality | Atorvastatin 20 mg | ||
| Total, all-cause mortality | Ezetimibe 10 mg/Simvastatin 40 mg | ||
| Total, all-cause mortality | Atorvastatin 40 mg | ||
| Total, other adverse events | Atorvastatin 10 mg | 26 | 257 |
| Total, other adverse events | Ezetimibe 10 mg/Simvastatin 20 mg | 32 | 256 |
| Total, other adverse events | Atorvastatin 20 mg | 26 | 258 |
| Total, other adverse events | Ezetimibe 10 mg/Simvastatin 40 mg | 32 | 257 |
| Total, other adverse events | Atorvastatin 40 mg | 30 | 256 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21029821 | RESULT |
Source PubMed
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/NCT00535405
GET https://conductscience.org/api/trials/v1/NCT00535405/results?page=2