The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3)

Merck Sharp & Dohme LLC46 enrolled

Overview

This study will investigate the effect of MK0859 on lipoprotein metabolism in patients with dyslipidemia already on statin therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dyslipidemia

Interventions

anacetrapibDRUG

\[Intervention Name: MK0859\] MK0859 100 mg tablet once daily for 8 weeks.

Comparator: atorvastatinDRUG

Atorvastatin 20 mg tablet once daily for 4 weeks in Period 1 and 8 weeks in Period 2.

Comparator: placebo to MK0859DRUG

Placebo to MK0859 once daily for 4 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient's weight has been stable for at least 6 weeks * Patient is in good health based on medical history, physical exam, and laboratory tests * Patient has dyslipidemia Exclusion Criteria : * Patient has a history of stroke, seizures, or major neurological disorders * Patient has a history of cancer * Patient is currently taking any lipid-lowering medications or substances except for statins * Patient consumes excessive amounts of alcohol or caffeine * Patient has multiple and/or severe allergies to food or drugs

Outcomes

Primary Outcomes

Difference in Production Rate (PR) and Fractional Catabolic Rate (FCR) of Low Density Lipoprotein (LDL) apoB100 following treatment with MK0859 and atorvastatin versus atorvastatin alone

Time frame: 12 weeks

Secondary Outcomes

Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo

Time frame: 12 weeks

Data from ClinicalTrials.gov

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