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

Tracking Information
First Submitted Date ICMJE	October 6, 2009
First Posted Date ICMJE	October 7, 2009
Last Update Posted Date	June 4, 2015
Study Start Date ICMJE	November 2009
Actual Primary Completion Date	June 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 6, 2009)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00990808 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 6, 2009)	Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3)
Official Title ICMJE	A Multiple Dose Study to Investigate the Effect of MK0859 on Lipoprotein Metabolism When Added to Ongoing Statin Therapy in Dyslipidemic Patients
Brief Summary	This study will investigate the effect of MK0859 on lipoprotein metabolism in patients with dyslipidemia already on statin therapy.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Dyslipidemia
Intervention ICMJE	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.
Study Arms	Experimental: Panel A Period 1: atorvastatin + placebo to MK0859; Period 2: atorvastatin + MK0859 Interventions: Drug: anacetrapib Drug: Comparator: atorvastatin Drug: Comparator: placebo to MK0859; Experimental: Panel B Period 1: placebo to atorvastatin + placebo to MK0859; Period 2: MK0859 + placebo to atorvastatin Interventions: Drug: anacetrapib Drug: Comparator: placebo to MK0859 Drug: Comparator: placebo to atorvastatin
Publications *	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.; Thomas T, Zhou H, Karmally W, Ramakrishnan R, Holleran S, Liu Y, Jumes P, Wagner JA, Hubbard B, Previs SF, Roddy T, Johnson-Levonas AO, Gutstein DE, Marcovina SM, Rader DJ, Ginsberg HN, Millar JS, Reyes-Soffer G. CETP (Cholesteryl Ester Transfer Protein) Inhibition With Anacetrapib Decreases Production of Lipoprotein(a) in Mildly Hypercholesterolemic Subjects. Arterioscler Thromb Vasc Biol. 2017 Sep;37(9):1770-1775. doi: 10.1161/ATVBAHA.117.309549. Epub 2017 Jul 20.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: July 24, 2013)	46
Original Estimated Enrollment ICMJE; (submitted: October 6, 2009)	40
Actual Study Completion Date	July 2011
Actual Primary Completion Date	June 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 70 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries	United States
Administrative Information
NCT Number ICMJE	NCT00990808
Other Study ID Numbers ICMJE	0859-026; 0859-026
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Merck Sharp & Dohme Corp.
Study Sponsor ICMJE	Merck Sharp & Dohme Corp.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account	Merck Sharp & Dohme Corp.
Verification Date	June 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP