NCT00269217CompletedPhase 3
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 1,400
- Primary Endpoint
- Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.
Secondary Outcomes
- 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.
Investigators
Similar Trials
Completed
Phase 3
Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)Primary HypercholesterolemiaMixed DyslipidemiaNCT00479388Merck Sharp & Dohme LLC1,216
Completed
Phase 3
Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)Mixed HyperlipidemiaNCT00289900Merck Sharp & Dohme LLC2,340
Completed
Phase 3
MK-0524B Lipid Study (MK-0524B-063)Primary HypercholesterolemiaMixed DyslipidemiaNCT00479882Merck Sharp & Dohme LLC2,414
Completed
Phase 3
Lipid Efficacy/Tolerability Study (0524A-020)Primary HypercholesterolaemiaMixed HyperlipidaemiaNCT00269204Merck Sharp & Dohme LLC1,620
Completed
Phase 3
A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial HypercholesterolemiaHeterozygous Familial HypercholesterolemiaNCT01968980Pfizer370