MK0524A Clinical Efficacy Study (0524A-026)(COMPLETED)

NCT ID: NCT00533312

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

PHASE2

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-01-31

Brief Summary

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A study to determine lipid changing effects of MK0524A when compared to niacin extended release (NIASPAN) and placebo.

Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Comparator : placebo (unspecified) / Duraton of Treatment: 4 Weeks

Intervention Type DRUG

MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks

Intervention Type DRUG

Comparator : niacin / Duraton of Treatment: 4 Weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must be between the ages of 18 and 70 years
* Female patients must be pre-menopausal women that have been surgically sterilized, not pregnant and/or not planning to become pregnant

Exclusion Criteria

* Patient has a history of peptic ulcer or gout
* Patient is sensitive to niacin or products containing niacin
* Patient drinks more than 2 alcoholic drinks per day
* Patient has certain heart disease, cancer, or is HIV positive
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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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Lai E, De Lepeleire I, Crumley TM, Liu F, Wenning LA, Michiels N, Vets E, O'Neill G, Wagner JA, Gottesdiener K. Suppression of niacin-induced vasodilation with an antagonist to prostaglandin D2 receptor subtype 1. Clin Pharmacol Ther. 2007 Jun;81(6):849-57. doi: 10.1038/sj.clpt.6100180. Epub 2007 Mar 28.

Reference Type RESULT
PMID: 17392721 (View on PubMed)

Study Documents

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Document Type: CSR Synopsis

View Document

Other Identifiers

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2007_619

Identifier Type: -

Identifier Source: secondary_id

0524A-026

Identifier Type: -

Identifier Source: org_study_id

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