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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092573
First received: September 23, 2004
Last updated: February 24, 2017
Last verified: February 2017
  Purpose
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
Hypercholesterolemia Hypertriglyceridemia Drug: MK0653, ezetimibe Drug: Comparator: fenofibrate monotherapy Phase 3

Study Type: Interventional
Study Design: 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.
  Eligibility

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
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 ClinicalTrials.gov identifier: 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
Study First Received: September 23, 2004
Last Updated: February 24, 2017

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

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

ClinicalTrials.gov processed this record on June 28, 2017