Back to resultsA Study of MK0859 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia (MK-0859-011)(COMPLETED)
Primary Purpose
Hypercholesterolemia, Hyperlipidemia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK0859
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- Patient is between 18 and 75 years of age
- Patient can be on a stable diet for the study
- Patient has a stable weight for more then 6 weeks before the study and has not participated in a weight loss program
Exclusion Criteria:
- Patient has chronic heart failure or a history of heart disease
- Patient has blood, digestive, or central nervous system disorders
- Patient is pregnant or nursing
- Patient is HIV positive
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00565292
First Posted
November 27, 2007
Last Updated
February 24, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00565292
Brief Title
A Study of MK0859 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia (MK-0859-011)(COMPLETED)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (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
This is a study to assess the safety, efficacy, and tolerability of MK0859 in patients with primary hypercholesterolemia (large amounts of cholesterol in the blood) or mixed hyperlipidemia (high levels of LDL cholesterol, triglycerides, and low levels of HDL cholesterol in blood) This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Hyperlipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0859
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:
Patient is between 18 and 75 years of age
Patient can be on a stable diet for the study
Patient has a stable weight for more then 6 weeks before the study and has not participated in a weight loss program
Exclusion Criteria:
Patient has chronic heart failure or a history of heart disease
Patient has blood, digestive, or central nervous system disorders
Patient is pregnant or nursing
Patient is HIV positive
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
18068514
Citation
Krishna R, Anderson MS, Bergman AJ, Jin B, Fallon M, Cote J, Rosko K, Chavez-Eng C, Lutz R, Bloomfield DM, Gutierrez M, Doherty J, Bieberdorf F, Chodakewitz J, Gottesdiener KM, Wagner JA. Effect of the cholesteryl ester transfer protein inhibitor, anacetrapib, on lipoproteins in patients with dyslipidaemia and on 24-h ambulatory blood pressure in healthy individuals: two double-blind, randomised placebo-controlled phase I studies. Lancet. 2007 Dec 8;370(9603):1907-14. doi: 10.1016/S0140-6736(07)61813-3.
Results Reference
derived
Learn more about this trial
A Study of MK0859 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia (MK-0859-011)(COMPLETED)
We'll reach out to this number within 24 hrs