Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)
Primary Purpose
Hypercholesterolemia, Hypertriglyceridemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0653, ezetimibe
Comparator: fenofibrate monotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring mixed hyperlipidemia, high cholesterol, high triglycerides
Eligibility Criteria
Inclusion Criteria: High cholesterol and high triglycerides Exclusion Criteria: Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study
Sites / Locations
Outcomes
Primary Outcome Measures
Plasma LDL-C vs. fenofibrate for 12 weeks.
Secondary Outcome Measures
All plasma lipid parameters vs. ezetimibe; all non-LDL lipid parameters vs. fenofibrate; safety and tolerability.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00092560
Brief Title
Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)
Official Title
Evaluation of the Efficacy and Safety of Fenofibrate and Ezetimibe Coadministration in Patients With Mixed Hyperlipidemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
December 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the cholesterol lowering effectiveness and safety of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).
Detailed Description
The duration of treatment is 18 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Hypertriglyceridemia
Keywords
mixed hyperlipidemia, high cholesterol, high triglycerides
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
587 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0653, ezetimibe
Intervention Type
Drug
Intervention Name(s)
Comparator: fenofibrate monotherapy
Primary Outcome Measure Information:
Title
Plasma LDL-C vs. fenofibrate for 12 weeks.
Secondary Outcome Measure Information:
Title
All plasma lipid parameters vs. ezetimibe; all non-LDL lipid parameters vs. fenofibrate; safety and tolerability.
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:
High cholesterol and high triglycerides
Exclusion Criteria:
Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study
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
15781429
Citation
Farnier M, Freeman MW, Macdonell G, Perevozskaya I, Davies MJ, Mitchel YB, Gumbiner B; Ezetimibe Study Group. Efficacy and safety of the coadministration of ezetimibe with fenofibrate in patients with mixed hyperlipidaemia. Eur Heart J. 2005 May;26(9):897-905. doi: 10.1093/eurheartj/ehi231. Epub 2005 Mar 21.
Results Reference
background
PubMed Identifier
22087637
Citation
Farnier M, Dong Q, Shah A, Johnson-Levonas AO, Brudi P. Low incidence of paradoxical reductions in HDL-C levels in dyslipidemic patients treated with fenofibrate alone or in combination with ezetimibe or ezetimibe/simvastatin. Lipids Health Dis. 2011 Nov 16;10:212. doi: 10.1186/1476-511X-10-212.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis Link
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)
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