Trial · NCT00496730
A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)
NCT00496730, Phase 3, Completed, Organon and Co; results first posted 2009-11-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED). Trials, record NCT00496730. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00496730
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)
- NCT number
- NCT00496730
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 256 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Hypercholesterolemia
- Interventions
- simvastatin (+) ezetimibe, Comparator: atorvastatin
- First posted
- 2007-07-04
- Last updated
- 2024-05-16
- Results first posted
- 2009-11-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks. | Baseline and 8 Weeks | |
| Secondary | Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. | Baseline and 8 weeks | Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. LDL-C goal is based on National Cholesterol Education Program (NCEP) III guideline (LDL-C goals and cutpoints for therapeutic life changes and drug Therapy in different risk). |
| Other | Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks. | Baseline and Week 8 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks. | Baseline and 8 Weeks | All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment. | Percent of Baseline Value | MEAN |
| SECONDARY | Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. | Baseline and 8 weeks | All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment. | Participants attaining LDL-C goal | NUMBER |
| OTHER_PRE_SPECIFIED | Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks. | Baseline and Week 8 | All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment. | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks. | Vytorin | -49.29 | Standard Deviation 15.22 | Percent of Baseline Value | |
| Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks. | Atorvastatin | -38.05 | Standard Deviation 12.28 | Percent of Baseline Value | |
| Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. | Vytorin | 105 | Participants attaining LDL-C goal | ||
| Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. | Atorvastatin | 93 | Participants attaining LDL-C goal | ||
| Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks. | Vytorin | 83.52 | Standard Deviation 33.84 | mg/dL | |
| Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks. | Atorvastatin | 98.27 | Standard Deviation 21.82 | mg/dL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vytorin | 130 | |
| Overall Study | STARTED | Atorvastatin | 126 | |
| Overall Study | COMPLETED | Vytorin | 124 | |
| Overall Study | COMPLETED | Atorvastatin | 121 | |
| Overall Study | NOT COMPLETED | Vytorin | 6 | |
| Overall Study | NOT COMPLETED | Atorvastatin | 5 |
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 | Hepatic enzyme increased | Investigations | Vytorin | 2 | 124 | 3 |
| other | Hepatic enzyme increased | Investigations | Atorvastatin | 3 | 121 | 4 |
| other | High Density lipoprotein decreased | Investigations | Vytorin | 2 | 124 | 2 |
| other | High Density lipoprotein decreased | Investigations | Atorvastatin | 5 | 121 | 5 |
| other | Blood Insulin Increased | Investigations | Vytorin | 2 | 124 | 2 |
| other | Blood Insulin Increased | Investigations | Atorvastatin | 0 | 121 | 0 |
| other | Blood creatine phosphokinase increased | Investigations | Vytorin | 1 | 124 | 1 |
| other | Blood creatine phosphokinase increased | Investigations | Atorvastatin | 0 | 121 | 0 |
| other | Blood Alkaline Phosphatase Increased | Investigations | Vytorin | 0 | 124 | 0 |
| other | Blood Alkaline Phosphatase Increased | Investigations | Atorvastatin | 1 | 121 | 1 |
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 | Vytorin | ||
| Total, all-cause mortality | Atorvastatin | ||
| Total, other adverse events | Vytorin | 25 | |
| Total, other adverse events | Atorvastatin | 29 | |
| Total, serious adverse events | Vytorin | 1 | |
| Total, serious adverse events | Atorvastatin | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00496730
GET https://conductscience.org/api/trials/v1/NCT00496730/events?page=2