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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Dyslipidemia

Treatments: Drug: Comparator: placebo to atorvastatin; Drug: Comparator: placebo to MK0859; Drug: anacetrapib; Drug: Comparator: atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00990808

0859-026

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Panel A

Experimental group

Description:

Period 1: atorvastatin + placebo to MK0859; Period 2: atorvastatin + MK0859

Treatment:

Drug: Comparator: placebo to MK0859

Drug: anacetrapib

Drug: Comparator: atorvastatin

Panel B

Experimental group

Description:

Period 1: placebo to atorvastatin + placebo to MK0859; Period 2: MK0859 + placebo to atorvastatin

Treatment:

Drug: Comparator: placebo to MK0859

Drug: anacetrapib

Drug: Comparator: placebo to atorvastatin