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NCT00378833 Clinical Trial

Tolerability of MK0524A Versus Niacin Extended-Release (0524A-054)

Hypercholesterolemia Clinical Trial

Official title:
A Worldwide, Multicenter, Double-Blind, Parallel Study to Evaluate the Tolerability of MK0524A Versus Niacin Extended-Release

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00378833
Other study ID # 0524A-054
Secondary ID 2006_529
Status Completed
Phase Phase 3
First received September 20, 2006
Last updated February 15, 2017
Start date July 2006
Est. completion date March 2007

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

Clinical Trial Summary

This is a 16-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the tolerability of MK0524A versus niacin extended-release. There will be 6 scheduled clinic visits and 2 treatment groups.

Recruitment information / eligibility
Status Completed
Enrollment 1300
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patient is an appropriate candidate for niacin therapy (at risk for heart disease) and triglycerides < 500 mg/dL

Exclusion Criteria:

- Patients with a history of any cardiovascular event directly linked to atherosclerosis with a low density lipoprotein-cholesterol (LDL-C) >/= 130 mg/dL and/or not on a statin

- Patients with diabetes and LDL-C >/= 130 mg/dL. Patients with >/= 2 heart disease risk factors and LDL-C >/= 160 mg/dL.

- Patients who have had a cardiovascular event (e.g., heart attack, stroke) within the previous 3 months.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• niacin (+) laropiprant
Duration of Treatment: 18 Weeks
• niacin
Duration of Treatment: 18 Weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Maccubbin D, Koren MJ, Davidson M, Gavish D, Pasternak RC, Macdonell G, Mallick M, Sisk CM, Paolini JF, Mitchel Y. Flushing profile of extended-release niacin/laropiprant versus gradually titrated niacin extended-release in patients with dyslipidemia with — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Global Flushing Severity Score (GFSS) over 16 weeks
Secondary Safety/tolerability
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