Trial · NCT00783263
A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)
NCT00783263, Phase 3, Completed, Organon and Co; results first posted 2011-09-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139). Trials, record NCT00783263. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00783263
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)
- NCT number
- NCT00783263
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 440 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Hypercholesterolemia
- Interventions
- Comparator: rosuvastatin 5 mg + ezetimibe 10 mg, Comparator: rosuvastatin 10 mg, Comparator: rosuvastatin 10 mg + ezetimibe 10 mg, Comparator: rosuvastatin 20 mg
- First posted
- 2008-10-31
- Last updated
- 2024-05-14
- Results first posted
- 2011-09-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment | Baseline to 6 weeks | The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment in participants who were administered ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks. |
| Secondary | Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum | Baseline to 6 weeks | The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment by stratum I and stratum II in participants who were administered with ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with the doubling of the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks. |
| Secondary | Number of Participants Who Reached Their Target LDL-C Level | 6 weeks of treatment | Participants were analyzed to evaluate the LDL-C (\<100 mg/dL for moderately high risk patients and high risk patients without AVD and \<70 mg/dL for high risk patients with AVD) lowering efficacy with the addition of ezetimibe 10 mg to (5 or 10 mg) compared with doubling the baseline rosuvastatin (10 or 20 mg), daily for 6 weeks of treatment. |
| Secondary | Number of Participants in Each Stratum Who Reached Their Target LDL-C Level | 6 weeks of treatment | Participants in stratum I were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 5 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 10 mg daily for 6 weeks. Participants in stratum II were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 10 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 20 mg daily for 6 weeks. |
| Secondary | Number of Participants Who Reached the LDL-C Level of <70 mg/dl | 6 weeks of treatment | Participants across all strata who reached the LDL-C Level of \<70 mg/dl after the addition of ezetimibe 10 mg to rosuvastatin (5 or 10 mg) daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks. |
| Secondary | Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl | 6 weeks of treatment | Participants in stratum I and in stratum II who reached the LDL-C Level of \<70 mg/dl after the addition of ezetimibe to rosuvastatin (5 or 10 mg)daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg). |
| Secondary | Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels | Baseline to 6 weeks | Participants who were analyzed to assess the Total Cholesterol (TC), Triglycerides, High-Density Lipoprotein Cholesterol, Non High-Density Lipoprotein Cholesterol, LDL Cholesterol/HDL Cholesterol, Total Cholesterol/HDL Cholesterol, Non-HDL Cholesterol/HDL Cholesterol, Apolipoprotein B (Apo B), Apolipoprotein A-I (Apo A-I), Apolipoprotein B/Apo A-I, high-sensitivity C-reactive protein (hs-CRP)levels after 6 weeks of treatment. |
Source ClinicalTrials.gov
Outcomes7
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-Cholesterol (mg/dL) After 6 Weeks of Treatment | Baseline to 6 weeks | percent change | MEAN | |
| SECONDARY | Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum | Baseline to 6 weeks | percentage change | MEAN | |
| SECONDARY | Number of Participants Who Reached Their Target LDL-C Level | 6 weeks of treatment | participants | NUMBER | |
| SECONDARY | Number of Participants in Each Stratum Who Reached Their Target LDL-C Level | 6 weeks of treatment | participants | NUMBER | |
| SECONDARY | Number of Participants Who Reached the LDL-C Level of <70 mg/dl | 6 weeks of treatment | participants | NUMBER | |
| SECONDARY | Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl | 6 weeks of treatment | participants | NUMBER | |
| SECONDARY | Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels | Baseline to 6 weeks | percentage change | MEAN |
Source ClinicalTrials.gov
Results by group40
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-Cholesterol (mg/dL) After 6 Weeks of Treatment | Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg | -21.57 | Standard Deviation 25.09 | percent change | |
| Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment | Rosuvastatin (10 or 20 mg) | -5.58 | Standard Deviation 25.42 | percent change | |
| Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum | Rosuvastatin 5 mg + Ezetimibe 10 mg (Stratum I) | -18.57 | Standard Deviation 26.35 | percentage change | |
| Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum | Rosuvastatin 10 mg (Stratum I) | -4.96 | Standard Deviation 22.42 | percentage change | |
| Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum | Rosuvastatin 10 mg + Ezetimibe 10 mg (Stratum II) | -24.00 | Standard Deviation 23.86 | percentage change | |
| Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum | Rosuvastatin 20 mg (Stratum II) | -6.07 | Standard Deviation 27.65 | percentage change | |
| Number of Participants Who Reached Their Target LDL-C Level | Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg | 130 | participants | ||
| Number of Participants Who Reached Their Target LDL-C Level | Rosuvastatin (10 or 20 mg) | 67 | participants | ||
| Number of Participants in Each Stratum Who Reached Their Target LDL-C Level | Rosuvastatin 5 mg + Ezetimibe 10 mg (Stratum I) | 54 | participants | ||
| Number of Participants in Each Stratum Who Reached Their Target LDL-C Level | Rosuvastatin 10 mg (Stratum I) | 30 | participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rosuvastatin 5 mg + Ezetimibe 10 mg | 99 | |
| Overall Study | STARTED | Rosuvastatin 10 mg | 98 | |
| Overall Study | STARTED | Rosuvastatin 10 mg + Ezetimibe 10 mg | 122 | |
| Overall Study | STARTED | Rosuvastatin 20 mg | 121 | |
| Overall Study | COMPLETED | Rosuvastatin 5 mg + Ezetimibe 10 mg | 95 | |
| Overall Study | COMPLETED | Rosuvastatin 10 mg | 96 | |
| Overall Study | COMPLETED | Rosuvastatin 10 mg + Ezetimibe 10 mg | 119 | |
| Overall Study | COMPLETED | Rosuvastatin 20 mg | 118 | |
| Overall Study | NOT COMPLETED | Rosuvastatin 5 mg + Ezetimibe 10 mg | 4 | |
| Overall Study | NOT COMPLETED | Rosuvastatin 10 mg | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events8
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 |
|---|---|---|---|---|---|---|
| serious | Sick sinus syndrome | Cardiac disorders | Rosuva 5 mg + EZ 10 mg | 0 | 99 | 0 |
| serious | Sick sinus syndrome | Cardiac disorders | Rosuva 10 mg | 0 | 98 | 0 |
| serious | Sick sinus syndrome | Cardiac disorders | Rosuva 10 mg + EZ 10 mg | 0 | 122 | 0 |
| serious | Sick sinus syndrome | Cardiac disorders | Rosuva 20 mg | 1 | 121 | 1 |
| serious | Tendon rupture | Injury, poisoning and procedural complications | Rosuva 5 mg + EZ 10 mg | 0 | 99 | 0 |
| serious | Tendon rupture | Injury, poisoning and procedural complications | Rosuva 10 mg | 1 | 98 | 1 |
| serious | Tendon rupture | Injury, poisoning and procedural complications | Rosuva 10 mg + EZ 10 mg | 0 | 122 | 0 |
| serious | Tendon rupture | Injury, poisoning and procedural complications | Rosuva 20 mg | 0 | 121 | 0 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rosuva 5 mg + EZ 10 mg | ||
| Total, all-cause mortality | Rosuva 10 mg | ||
| Total, all-cause mortality | Rosuva 10 mg + EZ 10 mg | ||
| Total, all-cause mortality | Rosuva 20 mg | ||
| Total, other adverse events | Rosuva 5 mg + EZ 10 mg | 0 | 99 |
| Total, other adverse events | Rosuva 10 mg | 0 | 98 |
| Total, other adverse events | Rosuva 10 mg + EZ 10 mg | 0 | 122 |
| Total, other adverse events | Rosuva 20 mg | 0 | 121 |
| Total, serious adverse events | Rosuva 5 mg + EZ 10 mg | 0 | 99 |
| Total, serious adverse events | Rosuva 10 mg | 1 | 98 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21596364 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg vs Rosuvastatin 10 or 20 mg: Number of Participants Who Reached the LDL-C Level of <70 mg/dl | Trial comparisons |
| Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg vs Rosuvastatin (10 or 20 mg): Number of Participants Who Reached Their Target LDL-C Level | Trial comparisons |
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/NCT00783263
GET https://conductscience.org/api/trials/v1/NCT00783263/results?page=2