Extended Release (ER) Niacin/Laropiprant Add on Study (0524A-082)

Merck Sharp & Dohme (MSD)

Status and phase: Withdrawn; Phase 3

Conditions: Dyslipidemia

Treatments: Drug: placebo (unspecified); Drug: niacin (+) laropiprant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00664287

0524A-082

2008_504

Details and patient eligibility

About

The purpose of this study is to test the effect of MK0524A (niacin (+) laropiprant) on lowering bad cholesterol and raising good cholesterol.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 18 years of age or older and on a stable dose of lipid therapy

Exclusion criteria

• Patients lipid level is outside the recommended range
• Patients that are HIV positive

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Group 1

Experimental group

Description:

Patients will remain on existing lipid-modifying therapy throughout the study. Group 1: Patients will receive ER niacin/laropiprant 1 g/20 mg daily. After 4 weeks, ER niacin/laropiprant will be increased to 2 g/40 mg for remainder of study.

Treatment:

Drug: niacin (+) laropiprant

Group 2

Placebo Comparator group

Description:

Patients will remain on existing lipid-modifying therapy throughout the study. Group 2: Patients will receive 1 placebo tablet daily. After 4 weeks, patients will be advanced to 2 placebo tablets for remainder of the study.

Treatment:

Drug: placebo (unspecified)