Phase 3
N=1,547
MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT01154036 ↗Enrolled (actual)
1,547
Serious AEs
1.0%
Results posted
Feb 2014
Primary outcome: Primary: Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I) — -24.8; -10.1; -13.8 Percentage Change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ezetimibe 10 mg (Drug); atorvastatin (Drug); Comparator: rosuvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I) |
-24.8; -10.1; -13.8 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II). |
-16.4; -8.1; -19.3; -8.4; 2.4 | <0.001 sig |
| SECONDARY Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I) |
56.3; 37.4; 43.6 | <0.001 sig |
| SECONDARY Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II) |
55.8; 34.1; 53.5; 35.8; NA | <0.001 sig |
| SECONDARY Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I) |
19.3; 3.0; 6.6 | <0.001 sig |
| SECONDARY Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II) |
18.3; 0.8; 15.4; 3.0; NA | 0.001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol (TC) (Phase I) |
-13.6; -6.3; -8.2 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol (TC) (Phase II) |
-10.2; -2.9; -13.1; -5.0; 2.2 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Triglycerides (TG) (Phase I) |
-6.0; -3.9; -1.1 | 0.466 |
| SECONDARY Percent Change From Baseline in Triglycerides (TG) (Phase II) |
-5.9; -3.1; -10.2; -3.2; NA | 0.466 |
| SECONDARY Percent Change From Baseline in High-density Lipoprotein-Cholesterol (HDL-C) (Phase I) |
0.9; -1.3; 1.0 | 0.133 |
| SECONDARY Percent Change From Baseline in HDL-C (Phase II) |
0.9; 1.0; -0.8; 0.0; 0.0 | 0.520 |
| SECONDARY Percent Change From Baseline in Apolipoprotein B (Apo B) (Phase I) |
-12.1; -6.1; -7.6 | 0.003 sig |
| SECONDARY Percent Change From Baseline in Apo B (Phase II) |
-12.0; -6.3; -14.0; -4.9; -4.0 | 0.079 |
| SECONDARY Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) (Phase I) |
-0.6; -1.9; 1.4 | 0.156 |
| SECONDARY Percent Change From Baseline in Apo A-I (Phase II) |
1.6; 1.4; -0.6; 0.0; -0.7 | 0.739 |
| SECONDARY Percent Change From Baseline in Non-HDL-C (Phase I) |
-18.0; -7.9; -11.1 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C (Phase II) |
-17.5; -5.5; -18.1; -6.3; -0.5 | <0.001 sig |
| SECONDARY Percent Change From Baseline in TC/HDL-C Ratio (Phase I) |
-14.3; -4.5; -9.0 | <0.001 sig |
| SECONDARY Percent Change From Baseline in TC/HDL-C Ratio (Phase II) |
-13.5; -6.5; -11.7; -4.0; -1.0 | <0.001 sig |
| SECONDARY Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase I) |
-23.9; -7.1; -14.7 | <0.001 sig |
| SECONDARY Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase II) |
-20.6; -8.2; -18.2; -7.5; -4.5 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase I) |
-13.0; -4.8; -8.8 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase II) |
-11.2; -6.4; -11.2; -5.4; -6.7 | 0.024 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase I) |
-18.9; -6.3; -12.2 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase II) |
-18.2; -8.8; -16.3; -5.9; -1.9 | <0.001 sig |
| SECONDARY Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) (Phase I) |
-10.5; -6.6; -9.0 | 0.613 |
| SECONDARY Percent Change From Baseline in Hs-CRP (Phase II) |
-19.5; -6.4; -10.9; 0.7; NA | 0.187 |
Summary
This study will compare the lipid-altering efficacy and safety of switching to co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or rosuvastatin in high cardiovascular risk patients with hypercholesterolemia who have not achieved specified low-density lipoprotein cholesterol (LDL-C) levels. The primary hypothesis is that the co-administration of ezetimibe 10 mg and atorvastatin 10 mg will be superior to both atorvastatin 20 mg and rosuvastatin 10 mg with respect to the percentage reduction in low-density lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.
Eligibility Criteria
Inclusion Criteria
- Patient is at high cardiovascular risk and meets one of the following conditions: has never taken lipid-lowering therapy or has been off such therapy for at least 6 weeks; or, is currently taking a stable dose of certain lipid-lowering agents
- Patient is willing to maintain a cholesterol lowering diet during the study
- Female patients receiving non-cyclical hormone therapy have maintained a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen during the study
Exclusion Criteria
- Patient is Asian
- Patient routinely has more than 2 alcoholic drinks per day
- Female patient is pregnant or breastfeeding
- Patient has congestive heart failure
- Patient has had a myocardial infarction, coronary bypass surgery, angioplasty, or acute coronary syndrome within 3 months of screening
- Patient has uncontrolled cardiac arrhythmias
- Patient has had a partial ileal or gastric bypass or other significant intestinal malabsorption
- Patient has uncontrolled high blood pressure
- Patient has kidney disease
- Patient has any disease known to influence blood lipid levels
- Patient has any disorders of the blood, digestive system, or nervous system including stroke and degenerative disease that would limit study participation
- Patient has poorly controlled or newly diagnosed diabetes
- Patient is known to be HIV positive
- Patient has a history of cancer in the last 5 years, except certain skin and cervical cancers
Data sourced from ClinicalTrials.gov (NCT01154036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.