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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00269217
Enrollment
1400
Registered
2005-12-23
Start date
2006-01-31
Completion date
2007-01-31
Last updated
2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hypercholesterolemia, Mixed Hyperlipidemia

Brief 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.

Interventions

DRUGniacin (+) laropiprant (+) simvastatin

Duration of Treatment 12 Weeks

DRUGComparator: niacin (+) laropiprant

Duration of Treatment 12 Weeks

DRUGComparator: simvastatin

Duration of Treatment 12 Weeks

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.—

Secondary

MeasureTime frame
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.—
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.—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026