Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Mixed Dyslipidemia; Primary Hypercholesterolemia

Treatments: Drug: Comparator: atorvastatin calcium; Drug: Comparator: simvastatin; Drug: niacin (+) laropiprant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00479388

0524A-067

2007_521

Details and patient eligibility

About

This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.

Enrollment: 1,216 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 18 to 80 years of age with Primary hypercholesterolemia or mixed dyslipidemia
• Patients will be eligible for the study if their LDL-C values are within protocol specified range and meet other entry criteria

Exclusion criteria

• Patient whose LDL-C values are not within protocol specified range

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,216 participants in 2 patient groups

1

Other group

Description:

One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.

Treatment:

Drug: niacin (+) laropiprant

2

Active Comparator group

Description:

Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.

Treatment:

Drug: Comparator: simvastatin

Drug: Comparator: atorvastatin calcium