Eze/Simva Switch Study in Diabetics (0653A-807)

Organon and Co648 enrolled

Overview

A study to assess the effectiveness and tolerability of MK0653A and MK0653A versus Atorvastatin in lowering LDL-C levels.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

648

Conditions

Diabetes Mellitus, Type 2

Interventions

MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 WeeksDRUG

Comparator: atorvastatin / Duration of Treatment: 6 WeeksDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Currently being treated with Atorvastatin 10 mg for at least 6 weeks * Have Type 2 Diabetes * Weight must be stable for more than 6 weeks before entering the study Exclusion Criteria: * Consume more than 14 alcoholic drinks per week. * Pregnant or lactating * Have taken another investigation drug within 3 months of starting this study * History of congestive heart failure, heart attack, coronary artery bypass surgery * Uncontrolled high blood pressure * HIV positive * History of cancer in the last 5 years

Outcomes

Primary Outcomes

Determine the additional LDL-C lowering achieved by switching to MK0653A as compared to Atorvastatin after 6 weeks of treatment

Time frame: 6 Weeks

Secondary Outcomes

Determine the effect of MK0653A versus Atorvastatin on total cholesterol after 6 weeks of treatment

Time frame: 6 Weeks

Data from ClinicalTrials.gov

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