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Phase 3 N=1,547 Randomized Double-blind Treatment

MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)

Hypercholesterolemia

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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