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

Primary Hypercholesterolemia Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Coadministered MK0524B Tablets in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269217
• Other study ID #: 0524B-022
• Secondary ID: MK0524B-0222005_
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2005
• Last updated: April 5, 2017
• Start date: January 2006
• Est. completion date: January 2007

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperlipidemia, Familial Combined
• Hyperlipidemias
• Hyperlipoproteinemia Type V
• Mixed Hyperlipidemia
• Primary Hypercholesterolemia

Intervention

Drug:
• niacin (+) laropiprant (+) simvastatin
Duration of Treatment 12 Weeks
• Comparator: niacin (+) laropiprant
Duration of Treatment 12 Weeks
• Comparator: simvastatin
Duration of Treatment 12 Weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.
Secondary	Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than simvastatin.
Secondary	Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than MK0524A.