A Study to Evaluate an Investigational Drug in Patients With Mixed Hyperlipidemia

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00093899
First received: October 7, 2004
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

The purpose of this study is to assess the cholesterol lowering effects of an investigational drug in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).


Condition Intervention Phase
Hyperlipidemia
Hypercholesterolemia
Hypertriglyceridemia
Drug: ezetimibe (+) simvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Fenofibrate Coadministration in Patients With Mixed Hyperlipidemia

Resource links provided by NLM:


Further study details as provided by Merck:

Primary Outcome Measures:
  • Plasma LDL-C.

Secondary Outcome Measures:
  • Plasma HDL-C, non-HDL-C, and TG. Tolerability

Estimated Enrollment: 600
Study Start Date: December 2004
Intervention Details:
    Drug: ezetimibe (+) simvastatin
    Duration of Treatment: 6 months
    Other Name: MK0653A
  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women 18-79 years of age with high cholesterol and high triglycerides.

Exclusion Criteria:

  • Individuals who do not meet specific cholesterol or triglyceride levels as required by the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093899

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00093899     History of Changes
Other Study ID Numbers: 2004_044, MK0653A-071
Study First Received: October 7, 2004
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Mixed Hyperlipidemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Hyperlipidemia, Familial Combined
Hypertriglyceridemia
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Simvastatin
Ezetimibe
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013