The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3)

Overview

This study will investigate the effect of MK0859 on lipoprotein metabolism in patients with dyslipidemia already on statin therapy.

Full Title of Study: “A Multiple Dose Study to Investigate the Effect of MK0859 on Lipoprotein Metabolism When Added to Ongoing Statin Therapy in Dyslipidemic Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 2011

Interventions

  • Drug: anacetrapib
    • [Intervention Name: MK0859] MK0859 100 mg tablet once daily for 8 weeks.
  • Drug: Comparator: atorvastatin
    • Atorvastatin 20 mg tablet once daily for 4 weeks in Period 1 and 8 weeks in Period 2.
  • Drug: Comparator: placebo to MK0859
    • Placebo to MK0859 once daily for 4 weeks.
  • Drug: Comparator: placebo to atorvastatin
    • Placebo to atorvastatin once daily for 4 weeks in Period 1 and 8 weeks in Period 2.

Arms, Groups and Cohorts

  • Experimental: Panel A
    • Period 1: atorvastatin + placebo to MK0859; Period 2: atorvastatin + MK0859
  • Experimental: Panel B
    • Period 1: placebo to atorvastatin + placebo to MK0859; Period 2: MK0859 + placebo to atorvastatin

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo
    • Time Frame: 12 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme Corp.

References

Millar JS, Reyes-Soffer G, Jumes P, Dunbar RL, deGoma EM, Baer AL, Karmally W, Donovan DS, Rafeek H, Pollan L, Tohyama J, Johnson-Levonas AO, Wagner JA, Holleran S, Obunike J, Liu Y, Ramakrishnan R, Lassman ME, Gutstein DE, Ginsberg HN, Rader DJ. Anacetrapib lowers LDL by increasing ApoB clearance in mildly hypercholesterolemic subjects. J Clin Invest. 2015 Jun;125(6):2510-22. doi: 10.1172/JCI80025. Epub 2015 May 11. Erratum in: J Clin Invest. 2016 Apr 1;126(4):1603-4.

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