Trial · NCT00462748
A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121)
NCT00462748, Phase 3, Completed, Organon and Co; results first posted 2009-08-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121). Trials, record NCT00462748. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00462748
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121)
- NCT number
- NCT00462748
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 786 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Hypercholesterolemia
- Interventions
- ezetimibe (+) simvastatin, Comparator: atorvastatin, Comparator: rosuvastatin
- First posted
- 2007-04-19
- Last updated
- 2024-05-16
- Results first posted
- 2009-08-17
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End | 6 Weeks | Fasting LDL-C was the primary efficacy variable. The primary efficacy analysis was based on the proportion of patients achieving a target of \<2mmol/l in fasting LDL-C at study end. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End | 6 Weeks | The Full Analysis Set (FAS) all patients who were:~* Randomised~* Took at least one dose of double-blind medication~* Had a baseline measurement of efficacy~* Had a post-baseline measurement of efficacy~Patients were analysed according to the treatment group they were randomised, regardless of the treatment they received | Percent | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End | Ezetimibe/Simvastatin | 67.4 | Percent | ||
| Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End | Atorvostatin | 36.3 | Percent | ||
| Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End | Rosuvastatin | 17.4 | Percent |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ezetimibe/Simvastatin | 261 | |
| Overall Study | STARTED | Atorvostatin | 263 | |
| Overall Study | STARTED | Rosuvastatin | 262 | |
| Overall Study | COMPLETED | Ezetimibe/Simvastatin | 249 | |
| Overall Study | COMPLETED | Atorvostatin | 252 | |
| Overall Study | COMPLETED | Rosuvastatin | 251 | |
| Overall Study | NOT COMPLETED | Ezetimibe/Simvastatin | 12 | |
| Overall Study | NOT COMPLETED | Atorvostatin | 11 | |
| Overall Study | NOT COMPLETED | Rosuvastatin | 11 |
Source ClinicalTrials.gov
Adverse events33
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 | Diarrhea | Gastrointestinal disorders | Ezetimibe/Simvastatin | 6 | 259 | 6 |
| other | Diarrhea | Gastrointestinal disorders | Atorvostatin | 1 | 260 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Rosuvastatin | 8 | 261 | 8 |
| serious | Platelet count decreased | Investigations | Ezetimibe/Simvastatin | 1 | 259 | 1 |
| serious | Platelet count decreased | Investigations | Atorvostatin | 0 | 260 | 0 |
| serious | Platelet count decreased | Investigations | Rosuvastatin | 0 | 261 | 0 |
| serious | Aortic regurgitation | Cardiac disorders | Ezetimibe/Simvastatin | 1 | 259 | 1 |
| serious | Aortic regurgitation | Cardiac disorders | Atorvostatin | 0 | 260 | 0 |
| serious | Aortic regurgitation | Cardiac disorders | Rosuvastatin | 0 | 261 | 0 |
| serious | Chest pain | General disorders | Ezetimibe/Simvastatin | 1 | 259 | 1 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 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 | Atorvostatin | ||
| Total, all-cause mortality | Rosuvastatin | ||
| Total, other adverse events | Ezetimibe/Simvastatin | 6 | |
| Total, other adverse events | Atorvostatin | 1 | |
| Total, other adverse events | Rosuvastatin | 8 | |
| Total, serious adverse events | Ezetimibe/Simvastatin | 4 | |
| Total, serious adverse events | Atorvostatin | 2 | |
| Total, serious adverse events | Rosuvastatin | 4 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20487050 | DERIVED |
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/NCT00462748
GET https://conductscience.org/api/trials/v1/NCT00462748/events?page=2