A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038)

Organon and Co1,398 enrolled

Overview

The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).

The duration of treatment is 4 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,398

Conditions

Hypercholesterolemia

Interventions

MK0653A, ezetimibe (+) simvastatinDRUG

Comparators: simvastatin and ezetimibeDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * High cholesterol Exclusion Criteria: * Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.

Outcomes

Primary Outcomes

Plasma LDL-C

Time frame: From baseline to study end point, defined in this study as the last available postbaseline LDL-C measurement, after 12 weeks of treatment.

Secondary Outcomes

Plasma LDL-C, TG and HDL-C. The proportion of patients achieving LDL-C targets. Tolerability.

Time frame: From baseline to study end point in TC, TG, HDL-C, ratios of direct LDL-C:HDL-C and TC:HDL-C, non-HDL-C, Apo B, Apo A-I, Apo A-II, Apo E, lipoprotein(a), C[1]reactive protein (CRP), and fibrinogen, after 12 weeks of treatment.

Data from ClinicalTrials.gov

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