Trial · NCT00409773
Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)
NCT00409773, Phase 3, Completed, Organon and Co; results first posted 2009-08-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED). Trials, record NCT00409773. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00409773
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)
- NCT number
- NCT00409773
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,143 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Hypercholesterolemia, Metabolic Syndrome
- Interventions
- ezetimibe (+) simvastatin, Comparator: atorvastatin calcium, Comparator: Placebo (unspecified)
- First posted
- 2006-12-11
- Last updated
- 2024-05-16
- Results first posted
- 2009-08-04
- Limitations and caveats
- 15 patients were randomized but not treated. Since these patients were not treated no Adverse Event Data was collected.
Source ClinicalTrials.gov
Registered outcomes15
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 6 | Baseline and 6 Weeks | |
| Secondary | Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6 | Baseline and 6 Weeks | |
| Secondary | Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6 | Baseline and 6 Weeks | |
| Secondary | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6 | Baseline and 6 Weeks | |
| Secondary | Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 | Baseline and 6 Weeks | |
| Secondary | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6 | Baseline and 6 Weeks | |
| Secondary | Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6 | Baseline and 6 Weeks | |
| Secondary | Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6 | Baseline and 6 Weeks | |
| Secondary | Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6 | Baseline and 6 Weeks | |
| Secondary | Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6 | Baseline and 6 Weeks |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
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 6 | Baseline and 6 Weeks | 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 Total Cholesterol(mg/dL) at Week 6 | Baseline and 6 Weeks | 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 Triglyceride (TG) (mg/dL) at Week 6 | Baseline and 6 Weeks | 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 | MEDIAN |
| SECONDARY | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6 | Baseline and 6 Weeks | 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 Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 | Baseline and 6 Weeks | 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 Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6 | Baseline and 6 Weeks | 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 Apolipoprotein- B (Apo-B) at Week 6 | Baseline and 6 Weeks | 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 Apolipoprotein-A1 (Apo-A1) at Week 6 | Baseline and 6 Weeks | 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 Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6 | Baseline and 6 Weeks | 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: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6 | Baseline and 6 Weeks | 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 15Source ClinicalTrials.gov
See all 15 outcomesResults by group75
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 6 | Atorva 10 mg | -36.5 | 95% Confidence Interval -38.9 to -34.0 | Percent Change | |
| Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6 | EZ/Simva 10 mg/20 mg | -49.6 | 95% Confidence Interval -52.0 to -47.2 | Percent Change | |
| Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6 | Atorva 20mg | -39.4 | 95% Confidence Interval -41.8 to -36.9 | Percent Change | |
| Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6 | EZ/Simva 10 mg/40 mg | -53.9 | 95% Confidence Interval -56.4 to -51.5 | Percent Change | |
| Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6 | Atorva 40 mg | -46.0 | 95% Confidence Interval -48.4 to -43.6 | Percent Change | |
| Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6 | Atorva 10 mg | -26.5 | 95% Confidence Interval -28.2 to -24.7 | Percent Change | |
| Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6 | EZ/Simva 10 mg/20 mg | -33.7 | 95% Confidence Interval -35.4 to -31.9 | Percent Change | |
| Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6 | Atorva 20mg | -28.3 | 95% Confidence Interval -30.1 to -26.6 | Percent Change | |
| Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6 | EZ/Simva 10 mg/40 mg | -37.3 | 95% Confidence Interval -39.0 to -35.5 | Percent Change | |
| Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6 | Atorva 40 mg | -32.8 | 95% Confidence Interval -34.6 to -31.1 | Percent Change |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atorva 10 mg | 229 | |
| Overall Study | STARTED | EZ/Simva 10 mg/20 mg | 229 | |
| Overall Study | STARTED | Atorva 20mg | 229 | |
| Overall Study | STARTED | EZ/Simva 10 mg/40 mg | 228 | |
| Overall Study | STARTED | Atorva 40 mg | 228 | |
| Overall Study | COMPLETED | Atorva 10 mg | 220 | |
| Overall Study | COMPLETED | EZ/Simva 10 mg/20 mg | 222 | |
| Overall Study | COMPLETED | Atorva 20mg | 220 | |
| Overall Study | COMPLETED | EZ/Simva 10 mg/40 mg | 216 | |
| Overall Study | COMPLETED | Atorva 40 mg | 218 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events150
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 | Any Gastrointestinal Disorders | Gastrointestinal disorders | Atorva 10 mg | 7 | 228 | |
| other | Any Gastrointestinal Disorders | Gastrointestinal disorders | EZ/Simva 10 mg/20 mg | 6 | 226 | |
| other | Any Gastrointestinal Disorders | Gastrointestinal disorders | Atorva 20mg | 7 | 226 | |
| other | Any Gastrointestinal Disorders | Gastrointestinal disorders | EZ/Simva 10 mg/40 mg | 4 | 224 | |
| other | Any Gastrointestinal Disorders | Gastrointestinal disorders | Atorva 40 mg | 2 | 224 | |
| other | Abdominal Tenderness | Gastrointestinal disorders | Atorva 10 mg | 1 | 228 | |
| other | Abdominal Tenderness | Gastrointestinal disorders | EZ/Simva 10 mg/20 mg | 2 | 226 | |
| other | Abdominal Tenderness | Gastrointestinal disorders | Atorva 20mg | 3 | 226 | |
| other | Abdominal Tenderness | Gastrointestinal disorders | EZ/Simva 10 mg/40 mg | 1 | 224 | |
| other | Abdominal Tenderness | Gastrointestinal disorders | Atorva 40 mg | 0 | 224 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atorva 10 mg | ||
| Total, all-cause mortality | EZ/Simva 10 mg/20 mg | ||
| Total, all-cause mortality | Atorva 20mg | ||
| Total, all-cause mortality | EZ/Simva 10 mg/40 mg | ||
| Total, all-cause mortality | Atorva 40 mg | ||
| Total, other adverse events | Atorva 10 mg | 21 | |
| Total, other adverse events | EZ/Simva 10 mg/20 mg | 14 | |
| Total, other adverse events | Atorva 20mg | 22 | |
| Total, other adverse events | EZ/Simva 10 mg/40 mg | 13 | |
| Total, other adverse events | Atorva 40 mg | 13 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
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/NCT00409773
GET https://conductscience.org/api/trials/v1/NCT00409773/results?page=2