Lipid Efficacy Study (0524B-022)(COMPLETED)

NCT ID: NCT00269217

Last Updated: 2017-04-07

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-01-31

Brief Summary

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This is a 12-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia, studying the effects of coadministered MK0524B on lipids. There will be 6 scheduled clinic visits, and 7 treatment arms.

Detailed Description

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Conditions

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Primary Hypercholesterolemia Mixed Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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niacin (+) laropiprant (+) simvastatin

Duration of Treatment 12 Weeks

Intervention Type DRUG

Comparator: niacin (+) laropiprant

Duration of Treatment 12 Weeks

Intervention Type DRUG

Comparator: simvastatin

Duration of Treatment 12 Weeks

Intervention Type DRUG

Other Intervention Names

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MK0524B MK0524A MK0733

Eligibility Criteria

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Inclusion Criteria

* Patients 18 to 85 years of age with primary hypercholesterolemia or mixed hyperlipidemia
* LDL-C between 130 and 190 mg/L (Category I) and 130 and 160 mg/L (Category II) and triglycerides \</= 350 mg/dL.

Exclusion Criteria

* A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study
* Patients with \<80% compliance
* Patients with certain medical conditions
* Patients taking certain concomitant medications and/or with unstable doses of medications
* Or those with a history of CHD/CHD equivalent or diabetes
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 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

References

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Farnier M, Chen E, Johnson-Levonas AO, McCrary Sisk C, Mitchel YB. Effects of extended-release niacin/laropiprant, simvastatin, and the combination on correlations between apolipoprotein B, LDL cholesterol, and non-HDL cholesterol in patients with dyslipidemia. Vasc Health Risk Manag. 2014 May 7;10:279-90. doi: 10.2147/VHRM.S58694. eCollection 2014.

Reference Type DERIVED
PMID: 24855368 (View on PubMed)

Ballantyne C, Gleim G, Liu N, Sisk CM, Johnson-Levonas AO, Mitchel Y. Effects of coadministered extended-release niacin/laropiprant and simvastatin on lipoprotein subclasses in patients with dyslipidemia. J Clin Lipidol. 2012 May-Jun;6(3):235-43. doi: 10.1016/j.jacl.2011.11.004. Epub 2011 Dec 3.

Reference Type DERIVED
PMID: 22658147 (View on PubMed)

Bays HE, Shah A, Lin J, Sisk CM, Dong Q, Maccubbin D. Consistency of extended-release niacin/laropiprant effects on Lp(a), ApoB, non-HDL-C, Apo A1, and ApoB/ApoA1 ratio across patient subgroups. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):197-206. doi: 10.2165/11631530-000000000-00000.

Reference Type DERIVED
PMID: 22500948 (View on PubMed)

Bays H, Shah A, Dong Q, McCrary Sisk C, Maccubbin D. Extended-release niacin/laropiprant lipid-altering consistency across patient subgroups. Int J Clin Pract. 2011 Apr;65(4):436-45. doi: 10.1111/j.1742-1241.2010.02620.x.

Reference Type DERIVED
PMID: 21401833 (View on PubMed)

Study Documents

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Document Type: CSR Synopsis Link

View Document

Other Identifiers

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MK0524B-022

Identifier Type: -

Identifier Source: secondary_id

2005_098

Identifier Type: -

Identifier Source: secondary_id

0524B-022

Identifier Type: -

Identifier Source: org_study_id

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