Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Mixed Hyperlipidemia

Treatments: Drug: Atorvastatin; Drug: MK-0524A; Drug: Simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00289900

MK-0524B-024 (Other Identifier)

2005_103

0524B-024

Details and patient eligibility

About

This is a 12-week clinical trial in participants with mixed hyperlipidemia to study the effects of MK-0524B on lipids.The primary hypothesis is that MK-0524B (dosed as MK-0524A coadministered with simvastatin) will be superior to atorvastatin on decreasing the low denisity lipoprotein cholesterol (LDL-C)/high-density lipoprotein cholesterol (HDL-C) ratio for the following dose comparisons: 2g/20 mg MK-0524B versus 10 mg atorvastatin, 2g/40 mg MK-0524B versus 20 mg atorvastatin, 2g/40 mg MK-0524B versus 40 mg atorvastatin, and 2g/40 mg MK-0524B versus 80 mg atorvastatin.

Enrollment: 2,340 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant 18 to 80 years of age with Mixed Hyperlipidemia with LDL-C between 130 and 190 mg/dL and Triglycerides between 150 and 500 mg/dL

Exclusion criteria

• Pregnant or lactating women, or women intending to become pregnant
• Diabetes mellitus that is poorly controlled, newly diagnosed, or taking new or recently adjusted antidiabetic therapy (with the exception of ± 10 units of insulin)
• Human immunodeficiency virus (HIV) positive
• Any of the following within the past 3 months: heart attack, stoke, heart bypass surgery, unstable angina, angioplasty
• Active or chronic liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,340 participants in 6 patient groups

MK-0524B 2g/20 mg

Experimental group

Description:

Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks

Treatment:

Drug: MK-0524A

Drug: Simvastatin

MK-0524B 2g/40mg

Experimental group

Description:

Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks

Treatment:

Drug: MK-0524A

Drug: Simvastatin

Atorvastatin 10 mg

Active Comparator group

Description:

Atorvastatin 10 mg, orally, once daily for 12 weeks

Treatment:

Drug: Atorvastatin

Atorvastatin 20 mg

Active Comparator group

Description:

Atorvastatin 20 mg, orally, once daily for 12 weeks

Treatment:

Drug: Atorvastatin

Atorvastatin 40 mg

Active Comparator group

Description:

Atorvastatin 40 mg, orally, once daily for 12 weeks

Treatment:

Drug: Atorvastatin

Atorvastatin 80 mg

Active Comparator group

Description:

Atorvastatin 80 mg, orally, once daily for 12 weeks

Treatment:

Drug: Atorvastatin