Effect of MK0524A on Flushing Caused by Niacin (0524A-056)

NCT ID: NCT00533611

Last Updated: 2017-02-17

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

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-08-31

Brief Summary

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The primary objective of the study is to assess the effects of MK0524A in reducing flushing associated with niacin.

Detailed Description

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Conditions

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Flushing

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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MK0524A, /Duration of Treatment : 4 Weeks

Intervention Type DRUG

Comparator : niacin /Duration of Treatment : 1 Weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient is male or female between 18 and 70 years of age
* Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study

Exclusion Criteria

* Patient has a history of hypersensitivity to niacin or niacin-containing products
* Patient is currently experiencing menopausal hot flashes
* Patient consumes more than 2 alcoholic beverages per day
* Patient has poorly controlled Type 1 or Type 2 diabetes mellitus
* Patient engages in vigorous exercise or an aggressive diet regimen
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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Kush D, Hu DY, Ye P, Kim HS, Chen E, Sirah W, McCrary Sisk C, Paolini JF, Maccubbin D. Flushing profile of extended-release niacin/laropiprant at initiation of therapy in Asian lipid clinic patients. Cardiology. 2009;114(3):192-8. doi: 10.1159/000228585. Epub 2009 Jul 15.

Reference Type BACKGROUND
PMID: 19602880 (View on PubMed)

Study Documents

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Document Type: CSR Synopsis

View Document

Other Identifiers

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MK0524A-056

Identifier Type: -

Identifier Source: secondary_id

2007_604

Identifier Type: -

Identifier Source: secondary_id

0524A-056

Identifier Type: -

Identifier Source: org_study_id

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