Trial · NCT00418834
Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)
NCT00418834, Phase 3, Completed, Organon and Co; results first posted 2009-10-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112). Trials, record NCT00418834. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00418834
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)
- NCT number
- NCT00418834
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,053 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Hypercholesterolemia
- Interventions
- ezetimibe and atorvastatin, atorvastatin, Placebo (unspecified)
- First posted
- 2007-01-05
- Last updated
- 2024-05-14
- Results first posted
- 2009-10-06
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in LDL-C at Week 6 | Baseline and Week 6 | |
| Secondary | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline and Week 12 | |
| Secondary | Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 | Week 6 | |
| Secondary | Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12 | Week 12 | |
| Secondary | Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6 | Week 6 | |
| Secondary | Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12 | Week 12 | |
| Other | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6 | Baseline and Week 6 | |
| Other | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline and Week 12 | |
| Other | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 | Baseline and Week 6 | |
| Other | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | Baseine and Week 12 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
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 LDL-C at Week 6 | Baseline and Week 6 | Full Analysis Set (FAS): The FAS population~includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at~least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication~were included in the analysis. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline and Week 12 | Full Analysis Set (FAS): The FAS~population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)~value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind~study medication were included in the analysis. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 | Week 6 | Full Analysis Set (FAS): The FAS population~includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at~least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication~were included in the analysis. | Participants | NUMBER |
| SECONDARY | Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12 | Week 12 | Full Analysis Set (FAS): The FAS~population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)~value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind~study medication were included in the analysis. | Participants | NUMBER |
| SECONDARY | Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6 | Week 6 | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Participants | NUMBER |
| SECONDARY | Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12 | Week 12 | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6 | Baseline and Week 6 | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Percent Change | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline and Week 12 | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Percent Change | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 | Baseline and Week 6 | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Percent Change | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | Baseine and Week 12 | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Percent Change | LEAST_SQUARES_MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group64
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 LDL-C at Week 6 | Atorva 10 mg + EZ | -26.7 | 95% Confidence Interval -28.6 to -24.7 | Percent Change | |
| Percent Change From Baseline in LDL-C at Week 6 | Atorva 20 mg / Atorva 40 mg | -12.8 | 95% Confidence Interval -14.8 to -10.9 | Percent Change | |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Atorva 10 mg + EZ | -22.5 | 95% Confidence Interval -25.0 to -19.9 | Percent Change | |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Atorva 20 mg / Atorva 40 mg | -17.9 | 95% Confidence Interval -20.5 to -15.4 | Percent Change | |
| Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 | Atorva 10 mg + EZ | <70 mg/dL | 244 | Participants | |
| Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 | Atorva 20 mg / Atorva 40 mg | <70 mg/dL | 92 | Participants | |
| Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 | Atorva 10 mg + EZ | ≥70 mg/dL | 271 | Participants | |
| Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 | Atorva 20 mg / Atorva 40 mg | ≥70 mg/dL | 423 | Participants | |
| Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12 | Atorva 10 mg + EZ | <70 mg/dL | 225 | Participants | |
| Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12 | Atorva 20 mg / Atorva 40 mg | <70 mg/dL | 164 | Participants |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atorva 10 mg + EZ | 526 | |
| Overall Study | STARTED | Atorva 20 mg / Atorva 40 mg | 527 | |
| Overall Study | COMPLETED | Atorva 10 mg + EZ | 503 | |
| Overall Study | COMPLETED | Atorva 20 mg / Atorva 40 mg | 507 | |
| Overall Study | NOT COMPLETED | Atorva 10 mg + EZ | 23 | |
| Overall Study | NOT COMPLETED | Atorva 20 mg / Atorva 40 mg | 20 |
Source ClinicalTrials.gov
Adverse events88
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 | Atorva 10 mg + EZ | 7 | 526 | |
| other | Constipation | Gastrointestinal disorders | Atorva 20 mg / Atorva 40 mg | 3 | 525 | |
| other | Bronchitis | Infections and infestations | Atorva 10 mg + EZ | 6 | 526 | |
| other | Bronchitis | Infections and infestations | Atorva 20 mg / Atorva 40 mg | 3 | 525 | |
| other | Nasopharyngitis | Infections and infestations | Atorva 10 mg + EZ | 6 | 526 | |
| other | Nasopharyngitis | Infections and infestations | Atorva 20 mg / Atorva 40 mg | 7 | 525 | |
| other | Upper respiratory tract infection | Infections and infestations | Atorva 10 mg + EZ | 7 | 526 | |
| other | Upper respiratory tract infection | Infections and infestations | Atorva 20 mg / Atorva 40 mg | 8 | 525 | |
| other | Asparate aminotransferase increased | Investigations | Atorva 10 mg + EZ | 2 | 526 | |
| other | Asparate aminotransferase increased | Investigations | Atorva 20 mg / Atorva 40 mg | 5 | 525 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atorva 10 mg + EZ | ||
| Total, all-cause mortality | Atorva 20 mg / Atorva 40 mg | ||
| Total, other adverse events | Atorva 10 mg + EZ | 46 | |
| Total, other adverse events | Atorva 20 mg / Atorva 40 mg | 54 | |
| Total, serious adverse events | Atorva 10 mg + EZ | 15 | |
| Total, serious adverse events | Atorva 20 mg / Atorva 40 mg | 14 |
Source ClinicalTrials.gov
Papers2
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 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/NCT00418834
GET https://conductscience.org/api/trials/v1/NCT00418834/registered?page=2