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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00990808

First received: October 6, 2009

Last updated: June 3, 2015

Last verified: June 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

October 6, 2009

Last Updated Date

June 3, 2015

Start Date ^ICMJE

November 2009

Primary Completion Date

June 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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.

* 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

Enrollment ^ICMJE

Completion Date

July 2011

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

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

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

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