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Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)

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ClinicalTrials.gov Identifier: NCT00092560
Recruitment Status : Completed
First Posted : September 28, 2004
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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).

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

Detailed Description:
The duration of treatment is 18 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 587 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 : December 2002
Actual Primary Completion Date : December 2003
Actual Study Completion Date : December 2003





Primary Outcome Measures :
  1. Plasma LDL-C vs. fenofibrate for 12 weeks.

Secondary Outcome Measures :
  1. All plasma lipid parameters vs. ezetimibe; all non-LDL lipid parameters vs. fenofibrate; safety and tolerability.


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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

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): NCT00092560


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

Study Data/Documents: CSR Synopsis Link  This link exits the ClinicalTrials.gov site

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092560     History of Changes
Other Study ID Numbers: 0653-036
2004_035
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
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