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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Hypercholesterolemia Mixed Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

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.

Group Type OTHER

niacin (+) laropiprant

Intervention Type DRUG

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

2

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

Group Type ACTIVE_COMPARATOR

Comparator: simvastatin

Intervention Type DRUG

simvastatin (20mg to 40mg) for 12 weeks.

Comparator: atorvastatin calcium

Intervention Type DRUG

atorvastatin calcium (20mg to 40mg) for 12 weeks.

Interventions

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Comparator: simvastatin

simvastatin (20mg to 40mg) for 12 weeks.

Intervention Type DRUG

niacin (+) laropiprant

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

Intervention Type DRUG

Comparator: atorvastatin calcium

atorvastatin calcium (20mg to 40mg) for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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Zocor® MK0524A atorvastatin

Eligibility Criteria

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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