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

Organon and Co1,547 enrolled

Overview

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.

This is a 18 week randomized, double-blind, active-controlled, multicenter study composed of a 6 week screening/run-in and 12 week double-blind treatment period (composed of 2 phases; each 6 weeks in duration). Only those participants who do not meet low density lipoprotein-cholesterol (LDL-C) goals at the end of Phase I (Week 6), were eligible to continue into Phase II (Week 12).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,547

Conditions

Hypercholesterolemia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (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).

Time frame: Baseline and Week 6 (end of Phase I )

Secondary Outcomes

Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II).

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).

Time frame: Baseline (Week 6) and Week 12

Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I)

Time frame: Week 6 (End of Phase I)

Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II)

Time frame: Week 12 (End of Phase II)

Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I)

Time frame: Week 6 (End of Phase I)

Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II)

Time frame: Week 12 (end of Phase II)

Percent Change From Baseline in Total Cholesterol (TC) (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