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

Flushing Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Tolerability and Effect of MK0524A on Niacin-Induced Acute Flushing in Lipid Clinic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533611
• Other study ID #: 0524A-056
• Secondary ID: MK0524A-0562007_
• Status: Completed
• Phase: Phase 3
• First received: September 19, 2007
• Last updated: February 16, 2017
• Start date: April 2007
• Est. completion date: August 2007

Study information

• Verified date: February 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Flushing

Intervention

Drug:
• MK0524A, /Duration of Treatment : 4 Weeks

• Comparator : niacin /Duration of Treatment : 1 Weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by maximum Global Flushing Severity Score (GFSS) categorized as none/mild, moderate, severe, extreme.		Over 1 week
Secondary	MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by (a) maximum daily GFSS; and (b) percentage of patients with a maximum GFSS =4 (moderate or greater).		Daily