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

Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990808
• Other study ID #: 0859-026
• Secondary ID: 0859-026
• Status: Completed
• Phase: Phase 1
• First received: October 6, 2009
• Last updated: June 3, 2015
• Start date: November 2009
• Est. completion date: July 2011

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 weeks	No
Secondary	Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo		12 weeks	No