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

NCT ID: NCT00664287

Last Updated: 2015-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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

Detailed Description

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Conditions

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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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Group 1

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.

Group Type EXPERIMENTAL

niacin (+) laropiprant

Intervention Type DRUG

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.

Group 2

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.

Group Type PLACEBO_COMPARATOR

placebo (unspecified)

Intervention Type DRUG

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.

Interventions

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niacin (+) laropiprant

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.

Intervention Type DRUG

placebo (unspecified)

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.

Intervention Type DRUG

Other Intervention Names

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MK0524A

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2008_504

Identifier Type: -

Identifier Source: secondary_id

0524A-082

Identifier Type: -

Identifier Source: org_study_id

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