Back to resultsMK0859 Dose-Ranging Study (0859-003)
Primary Purpose
Hypercholesterolemia, Mixed Hyperlipemia
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0859
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria: Eligible patients will be men and women of non-child bearing potential, 18 through 75 years of age diagnosed with high cholesterol Exclusion Criteria: Patients with CHD or CHD-equivalent disease (except diabetes) Diabetics on statins
Sites / Locations
Outcomes
Primary Outcome Measures
To assess the cholesterol changing effects of MK0859
Secondary Outcome Measures
Acceptable safety profile
Full Information
NCT ID
NCT00325455
First Posted
May 11, 2006
Last Updated
February 27, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00325455
Brief Title
MK0859 Dose-Ranging Study (0859-003)
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of MK-0859 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Study Start Date
June 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
To assess the cholesterol changing effects of MK0859 in patients with primary hypercholesterolemia or mixed dyslipidemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Mixed Hyperlipemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0859
Primary Outcome Measure Information:
Title
To assess the cholesterol changing effects of MK0859
Secondary Outcome Measure Information:
Title
Acceptable safety profile
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eligible patients will be men and women of non-child bearing potential, 18 through 75 years of age diagnosed with high cholesterol
Exclusion Criteria:
Patients with CHD or CHD-equivalent disease (except diabetes)
Diabetics on statins
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21982664
Citation
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.
Results Reference
result
PubMed Identifier
25670366
Citation
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.
Results Reference
derived
Learn more about this trial
MK0859 Dose-Ranging Study (0859-003)
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