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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 23, 2004
Last updated: February 17, 2015
Last verified: February 2015

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 Intervention Phase
Drug: MK0653, ezetimibe
Drug: Comparator: fenofibrate monotherapy
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of Fenofibrate and Ezetimibe Coadministration in Patients With Mixed Hyperlipidemia

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Tolerability

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

Enrollment: 576
Study Start Date: April 2003
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Detailed Description:

The duration of treatment is 48 weeks.


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00092573

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

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00092573     History of Changes
Other Study ID Numbers: 0653-036 Extension, 2004_036
Study First Received: September 23, 2004
Last Updated: February 17, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hyperlipidemia, Familial Combined
Hyperlipoproteinemia Type V
Genetic Diseases, Inborn
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Metabolic Diseases
Metabolism, Inborn Errors
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on October 09, 2015