A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Dyslipidemia

Treatments: Drug: Comparator: Placebo; Drug: Comparator: atorvastatin; Drug: anacetrapib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00977288

0859-029

2009_662

Details and patient eligibility

About

This study will investigate the effect of MK0859 when administered alone and when in combination with atorvastatin in lowering Low Density Lipoprotein -Cholesterol (LDL-C) in Japanese patients with dyslipidemia.

Full description

This is the dose ranging study to evaluate efficacy and safety of MK-0859 in Japanese patients.

Eligible patients were assigned to 1 of 10 treatment groups (including treatment groups with or without administrative atorvastatin) for an 8-week treatment period which was followed by a 8-week reversibility period.

As an additional follow-up, the pregnancy information from women of childbearing potential who were treated with MK-0859 in this study will be collected retrospectively for a period of 4 years after the last dose of MK-0859.

Enrollment: 408 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is male or female and between the ages of 20 and 75 years diagnosed with dyslipidemia

Exclusion criteria

• Patients has Coronary Heart Disease (CHD) or CHD-equivalent disease (except diabetes)
• Patients has uncontrolled diabetes
• Patient is currently participating or has participated in a study with an investigational compound within the last 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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408 participants in 10 patient groups, including a placebo group

1

Experimental group

Description:

MK0859 10 mg + placebo

Treatment:

Drug: Comparator: Placebo

Drug: anacetrapib

2

Experimental group

Description:

MK0859 40 mg + placebo

Treatment:

Drug: Comparator: Placebo

Drug: anacetrapib

3

Experimental group

Description:

MK0859 100 mg + placebo

Treatment:

Drug: Comparator: Placebo

Drug: anacetrapib

4

Experimental group

Description:

MK0859 300 mg + placebo

Treatment:

Drug: Comparator: Placebo

Drug: anacetrapib

5

Experimental group

Description:

MK0859 10 mg + atorvastatin 10mg

Treatment:

Drug: Comparator: atorvastatin

Drug: anacetrapib

6

Experimental group

Description:

MK0859 40 mg + atorvastatin 10mg

Treatment:

Drug: Comparator: atorvastatin

Drug: anacetrapib

7

Experimental group

Description:

MK0859 100 mg + atorvastatin 10mg

Treatment:

Drug: Comparator: atorvastatin

Drug: anacetrapib

8

Experimental group

Description:

MK0859 300 mg + atorvastatin 10mg

Treatment:

Drug: Comparator: atorvastatin

Drug: anacetrapib

9

Placebo Comparator group

Description:

Placebo + atorvastatin 10mg

Treatment:

Drug: Comparator: atorvastatin

Drug: Comparator: Placebo

10

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo