NCT00325455

Brief Summary

To assess the cholesterol changing effects of MK0859 in patients with primary hypercholesterolemia or mixed dyslipidemia.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_2

Status
terminated

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

May 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2006

Completed
20 days until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

March 2, 2015

Status Verified

February 1, 2015

Enrollment Period

8 months

First QC Date

May 11, 2006

Last Update Submit

February 27, 2015

Conditions

HypercholesterolemiaMixed Hyperlipemia

Outcome Measures

Primary Outcomes (1)

  • To assess the cholesterol changing effects of MK0859

Secondary Outcomes (1)

  • Acceptable safety profile

Interventions

MK0859DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible patients will be men and women of non-child bearing potential, 18 through 75 years of age diagnosed with high cholesterol

You may not qualify if:

  • Patients with CHD or CHD-equivalent disease (except diabetes)
  • Diabetics on statins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Dansky HM, Bloomfield D, Gibbons P, Liu S, Sisk CM, Tribble D, McKenney JM, Littlejohn TW 3rd, Mitchel Y. Efficacy and safety after cessation of treatment with the cholesteryl ester transfer protein inhibitor anacetrapib (MK-0859) in patients with primary hypercholesterolemia or mixed hyperlipidemia. Am Heart J. 2011 Oct;162(4):708-16. doi: 10.1016/j.ahj.2011.07.010. Epub 2011 Sep 1.

    PMID: 21982664RESULT

  • Krauss RM, Pinto CA, Liu Y, Johnson-Levonas AO, Dansky HM. Changes in LDL particle concentrations after treatment with the cholesteryl ester transfer protein inhibitor anacetrapib alone or in combination with atorvastatin. J Clin Lipidol. 2015 Jan-Feb;9(1):93-102. doi: 10.1016/j.jacl.2014.09.013. Epub 2014 Oct 13.

    PMID: 25670366DERIVED

MeSH Terms

Conditions

HypercholesterolemiaHyperlipoproteinemia Type V

Interventions

anacetrapib

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHypertriglyceridemia

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2006

First Posted

May 12, 2006

Study Start

June 1, 2006

Primary Completion

February 1, 2007

Study Completion

March 1, 2007

Last Updated

March 2, 2015

Record last verified: 2015-02