Trial · NCT01154036
MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)
NCT01154036, Phase 3, Completed, Organon and Co; results first posted 2014-02-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162). Trials, record NCT01154036. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01154036
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)
- NCT number
- NCT01154036
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,547 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Hypercholesterolemia
- Interventions
- ezetimibe 10 mg, atorvastatin, Comparator: rosuvastatin
- First posted
- 2010-06-30
- Last updated
- 2022-02-09
- Results first posted
- 2014-02-12
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 Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I) | Baseline and Week 6 (end of Phase I ) | LDL-C levels measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. LDL-C was calculated using the Friedewald method when triglyceride (TG)\<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG≥350 mg/dL (3.95 mmol/L). |
| Secondary | Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II). | Baseline (Week 6) and Week 12 | LDL-C levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12). Baseline was defined as the average of the values at Visits 5 and 6. LDL-C was calculated using the Friedewald method when triglyceride (TG)\<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG ≥350 mg/dL (3.95 mmol/L). |
| Secondary | Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I) | Week 6 (End of Phase I) | |
| Secondary | Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II) | Week 12 (End of Phase II) | |
| Secondary | Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I) | Week 6 (End of Phase I) | |
| Secondary | Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II) | Week 12 (end of Phase II) | |
| Secondary | Percent Change From Baseline in Total Cholesterol (TC) (Phase I) | Baseline and Week 6 (end of Phase I) | TC measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4 |
| Secondary | Percent Change From Baseline in Total Cholesterol (TC) (Phase II) | Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) | TC levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. |
| Secondary | Percent Change From Baseline in Triglycerides (TG) (Phase I) | Baseline and Week 6 (end of Phase I) | TG measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment. |
| Secondary | Percent Change From Baseline in Triglycerides (TG) (Phase II) | Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) | TG levels measured at Baseline (Week 6: end of Phase I) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment. |
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 Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I) | Baseline and Week 6 (end of Phase I ) | Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participant who received at least one dose of study drug during Phase I and had a baseline or at least one measurement available during Phase I | Percentage Change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II). | Baseline (Week 6) and Week 12 | Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II | Percentage Change | MEDIAN |
| SECONDARY | Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I) | Week 6 (End of Phase I) | Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II) | Week 12 (End of Phase II) | Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I) | Week 6 (End of Phase I) | Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II) | Week 12 (end of Phase II) | Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II | Percentage of Participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Total Cholesterol (TC) (Phase I) | Baseline and Week 6 (end of Phase I) | Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I. | Percentage Change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Total Cholesterol (TC) (Phase II) | Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) | Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II | Percentage Change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Triglycerides (TG) (Phase I) | Baseline and Week 6 (end of Phase I) | Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I. | Percentage Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Triglycerides (TG) (Phase II) | Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) | Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II | Percentage Change | LEAST_SQUARES_MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group112
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-Cholesterol (LDL-C) (Phase I) | Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | -24.8 | Standard Deviation 23.6 | Percentage Change | |
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I) | Phase I: Atorvastatin 20 mg | -10.1 | Standard Deviation 20.8 | Percentage Change | |
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I) | Phase I: Rosuvastatin 10 mg | -13.8 | Standard Deviation 22.8 | Percentage Change | |
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II). | Phase II: EZ 10mg + Atorva 20mg [A] | -16.4 | Standard Deviation 31.1 | Percentage Change | |
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II). | Phase II: Atorva 40mg | -8.1 | Standard Deviation 23.3 | Percentage Change | |
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II). | Phase II: EZ 10mg + Atorva 20mg [R] | -19.3 | Standard Deviation 32.1 | Percentage Change | |
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II). | Phase II: Rosuvastatin 20mg | -8.4 | Standard Deviation 20.8 | Percentage Change | |
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II). | Phase II: EZ 10mg+Atorva 10mg | 2.4 | Standard Deviation 27.4 | Percentage Change | |
| Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I) | Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | 56.3 | 4.55 | Percentage of Participants | |
| Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I) | Phase I: Atorvastatin 20 mg | 37.4 | 2.23 | Percentage of Participants |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I | STARTED | Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | 120 | |
| Phase I | STARTED | Phase I: Atorvastatin 20 mg | 483 | |
| Phase I | STARTED | Phase I: Rosuvastatin 10 mg | 944 | |
| Phase I | STARTED | Phase II: EZ 10mg+Atorva 10mg | 0 | |
| Phase I | STARTED | Phase II: EZ 10mg + Atorva 20mg [A] | 0 | |
| Phase I | STARTED | Phase II: Atorva 40mg | 0 | |
| Phase I | STARTED | Phase II: EZ 10mg + Atorva 20mg [R] | 0 | |
| Phase I | STARTED | Phase II: Rosuvastatin 20mg | 0 | |
| Phase I | COMPLETED | Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | 117 | |
| Phase I | COMPLETED | Phase I: Atorvastatin 20 mg | 455 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events224
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 | Anaemia | Blood and lymphatic system disorders | Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | 0 | 120 | 0 |
| serious | Anaemia | Blood and lymphatic system disorders | Phase I: Atorvastatin 20 mg | 0 | 480 | 0 |
| serious | Anaemia | Blood and lymphatic system disorders | Phase I: Rosuvastatin 10 mg | 1 | 939 | 1 |
| serious | Anaemia | Blood and lymphatic system disorders | Phase II: EZ 10mg+Atorva 10mg | 0 | 28 | 0 |
| serious | Anaemia | Blood and lymphatic system disorders | Phase II: EZ 10mg + Atorva 20mg [A] | 0 | 124 | 0 |
| serious | Anaemia | Blood and lymphatic system disorders | Phase II: Atorva 40mg | 0 | 124 | 0 |
| serious | Anaemia | Blood and lymphatic system disorders | Phase II: EZ 10mg + Atorva 20mg [R] | 0 | 231 | 0 |
| serious | Anaemia | Blood and lymphatic system disorders | Phase II: Rosuvastatin 20mg | 0 | 205 | 0 |
| serious | Acute myocardial infarction | Cardiac disorders | Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | 0 | 120 | 0 |
| serious | Acute myocardial infarction | Cardiac disorders | Phase I: Atorvastatin 20 mg | 0 | 480 | 0 |
1 to 10 of 224Source ClinicalTrials.gov
See all 224 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | ||
| Total, all-cause mortality | Phase I: Atorvastatin 20 mg | ||
| Total, all-cause mortality | Phase I: Rosuvastatin 10 mg | ||
| Total, all-cause mortality | Phase II: EZ 10mg+Atorva 10mg | ||
| Total, all-cause mortality | Phase II: EZ 10mg + Atorva 20mg [A] | ||
| Total, all-cause mortality | Phase II: Atorva 40mg | ||
| Total, all-cause mortality | Phase II: EZ 10mg + Atorva 20mg [R] | ||
| Total, all-cause mortality | Phase II: Rosuvastatin 20mg | ||
| Total, other adverse events | Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | 0 | 120 |
| Total, other adverse events | Phase I: Atorvastatin 20 mg | 0 | 480 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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/NCT01154036
GET https://conductscience.org/api/trials/v1/NCT01154036/registered?page=2