NCT00990808

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2009

Completed
25 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

1.6 years

First QC Date

October 6, 2009

Last Update Submit

June 3, 2015

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo

    12 weeks

Study Arms (2)

Panel A

EXPERIMENTAL

Period 1: atorvastatin + placebo to MK0859; Period 2: atorvastatin + MK0859

Drug: anacetrapibDrug: Comparator: atorvastatinDrug: Comparator: placebo to MK0859

Panel B

EXPERIMENTAL

Period 1: placebo to atorvastatin + placebo to MK0859; Period 2: MK0859 + placebo to atorvastatin

Drug: anacetrapibDrug: Comparator: placebo to MK0859Drug: Comparator: placebo to atorvastatin

Interventions

anacetrapibDRUG

\[Intervention Name: MK0859\] MK0859 100 mg tablet once daily for 8 weeks.

Panel APanel B
Comparator: atorvastatinDRUG

Atorvastatin 20 mg tablet once daily for 4 weeks in Period 1 and 8 weeks in Period 2.

Panel A
Comparator: placebo to MK0859DRUG

Placebo to MK0859 once daily for 4 weeks.

Panel APanel B
Comparator: placebo to atorvastatinDRUG

Placebo to atorvastatin once daily for 4 weeks in Period 1 and 8 weeks in Period 2.

Panel B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 25961461BACKGROUND

  • 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.

    PMID: 28729361DERIVED

MeSH Terms

Conditions

Dyslipidemias

Interventions

anacetrapib

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2009

First Posted

October 7, 2009

Study Start

November 1, 2009

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

June 4, 2015

Record last verified: 2015-06