A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)

Organon and Co618 enrolled

Overview

This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

618

Conditions

Hypercholesterolemia

Interventions

ezetimibe (+) simvastatinDRUG

ezetimibe/simvastatin 10/20mg. The treatment duration will be 6 weeks.

Comparator : rosuvastatin calciumDRUG

rosuvastatin 10mg. The treatment duration will be 6 weeks.

Comparator: Placebo (unspecified)DRUG

rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant is currently taking a statin medication for the treatment of high cholesterol * Participant has an LDL-C level that is greater than or equal to 100 mg/dl and less than or equal to 190 mg/dl Exclusion Criteria: * Women who are pregnant or nursing, or women who intend to become pregnant * Participant has any condition, situation, or is currently taking any medication that might pose a risk to the participant or interfere with participation in the study

Outcomes

Primary Outcomes

Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment

Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure \*100.

Time frame: Baseline and 6 weeks

Secondary Outcomes

The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment

The percentage of participants who achieved a target LDL-C goal of \< 100 mg/dL, of \<70 mg/dL, and of \<77 mg/dL at study endpoint after six weeks of treatment. The numerator is the number of participants in a treatment group who achieved a target LDL-C goal and the denominator is the total number of participants within that treatment group.

Time frame: after 6 weeks of treatment

Data from ClinicalTrials.gov

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