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Study of Ezetimibe and Fenofibrate in Patients With Mixed Hyperlipidemia (0653-036)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00092573
Recruitment Status : Completed
First Posted : September 28, 2004
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assess the cholesterol lowering safety and effectiveness of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Hypertriglyceridemia Drug: MK0653, ezetimibe Drug: Comparator: fenofibrate monotherapy Phase 3

Detailed Description:
The duration of treatment is 48 weeks.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 576 participants
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of Fenofibrate and Ezetimibe Coadministration in Patients With Mixed Hyperlipidemia
Study Start Date : April 2003
Primary Completion Date : November 2004
Study Completion Date : November 2004


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Tolerability

Secondary Outcome Measures :
  1. Plasma LDL-C, HDL-C and triglycerides after 12 weeks.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092573


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Publications:
Study Data/Documents: CSR Snyopsis  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092573     History of Changes
Other Study ID Numbers: 0653-036 Extension
2004_036
First Posted: September 28, 2004    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Mixed hyperlipidemia (high cholesterol and high triglycerides)

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Hyperlipoproteinemias
Hypertriglyceridemia
Hyperlipidemia, Familial Combined
Hyperlipoproteinemia Type V
Lipidoses
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Ezetimibe
Fenofibrate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents