NCT00990808CompletedPhase 1
A Multiple Dose Study to Investigate the Effect of MK0859 on Lipoprotein Metabolism When Added to Ongoing Statin Therapy in Dyslipidemic Patients
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 46
- Primary Endpoint
- Difference in Production Rate (PR) and Fractional Catabolic Rate (FCR) of Low Density Lipoprotein (LDL) apoB100 following treatment with MK0859 and atorvastatin versus atorvastatin alone
Study Overview
Brief Summary
This study will investigate the effect of MK0859 on lipoprotein metabolism in patients with dyslipidemia already on statin therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient's weight has been stable for at least 6 weeks
- •Patient is in good health based on medical history, physical exam, and laboratory tests
- •Patient has dyslipidemia
- •Exclusion Criteria :
- •Patient has a history of stroke, seizures, or major neurological disorders
- •Patient has a history of cancer
- •Patient is currently taking any lipid-lowering medications or substances except for statins
- •Patient consumes excessive amounts of alcohol or caffeine
- •Patient has multiple and/or severe allergies to food or drugs
Exclusion Criteria
- Not provided
Arms & Interventions
Panel A
Experimental
Period 1: atorvastatin + placebo to MK0859; Period 2: atorvastatin + MK0859
Intervention: anacetrapib (Drug)
Panel B
Experimental
Period 1: placebo to atorvastatin + placebo to MK0859; Period 2: MK0859 + placebo to atorvastatin
Intervention: anacetrapib (Drug)
Outcomes
Primary Outcomes
Difference in Production Rate (PR) and Fractional Catabolic Rate (FCR) of Low Density Lipoprotein (LDL) apoB100 following treatment with MK0859 and atorvastatin versus atorvastatin alone
Time Frame: 12 weeks
Secondary Outcomes
- Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo(12 weeks)
Investigators
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