A Study of MK-6213 Co-Administered With Atorvastatin in Participants With Hypercholesterolemia (MK-6213-006)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: Placebo for MK-6312 160 mg; Drug: MK-6213; Drug: Atorvastatin calcium; Drug: Placebo for Atorvastatin 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00687271

MK-6314-006 (Other Identifier)

2007_514 (Other Identifier)

6213-006

2007-003684-41 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to test the safety and effectiveness of MK-6213 as compared to MK-6213/Atorvastatin in participants 18 to 75 years) with high cholesterol.

Enrollment: 334 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 75 years of age at the time of the study with high cholesterol
• Can have diabetes mellitus but is not currently on lipid lowering therapy
• Have a stable weight for >6 weeks

Exclusion criteria

• Has significant cardiovascular (heart), renal (kidney), neurologic (nervous system), respiratory (lung), hepatic (liver) or metabolic disease
• history of mental instability or drug/alcohol abuse within the past 5 years
• Pregnant or nursing; human immunodeficiency virus (HIV) positive; history of cancer within the past 5 years or participation in an investigational trial within the last 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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334 participants in 4 patient groups, including a placebo group

MK-6213 160 mg + Atorvastatin 20 mg

Experimental group

Description:

1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks

Treatment:

Drug: MK-6213

Drug: Atorvastatin calcium

Atorvastatin 20 mg

Active Comparator group

Description:

1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks

Treatment:

Drug: Placebo for MK-6312 160 mg

Drug: Atorvastatin calcium

MK-6213 160 mg

Experimental group

Description:

1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks

Treatment:

Drug: Placebo for Atorvastatin 20 mg

Drug: MK-6213

Placebo

Placebo Comparator group

Description:

1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks

Treatment:

Drug: Placebo for MK-6312 160 mg

Drug: Placebo for Atorvastatin 20 mg