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A 16 Week Comparative Study of Fenofibrate Versus Ezetimibe as Add-on Therapy to Atorvastatin
This study has been completed.
First Received: September 14, 2005   Last Updated: October 2, 2007   History of Changes
Sponsor: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00195793
  Purpose

The objective of this study is to evaluate the effects of adding Tricor 145 mg to once daily atorvastatin 20 mg on CHD lipid laboratory parameters.


Condition Intervention Phase
Hyperlipidemia
Drug: fenofibrate
Drug: ezetimibe
Drug: atorvastatin
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
Official Title: A Multicenter, Randomized, Double-Blind, Prospective, Parallel Study to Compare the Safety and Efficacy of Fenofibrate or Ezetimibe as Add-On Therapy to Atorvastatin in Subjects With Combined Hyperlipidemia, Typical of the Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Percent change from Combination Baseline to 12 weeks post-Combination Baseline in direct measured HDL-C and TG. [ Time Frame: Week 12 ]

Secondary Outcome Measures:
  • Advanced lipid and inflammatory parameters [ Time Frame: Week 12 ]

Enrollment: 174
Study Start Date: August 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is >= 18 years of age, any race, and any gender.
  • Subjects must have the following fasting parameters:

    • LDL-C > 100 mg/dL and < 190 mg/dL.
    • TG level >= 175 mg/dL and < 1000 mg/dL.
    • HDL-C < 40 mg/dL (men) and < 50 mg/dL (women).
  • Subjects must have one or more of the following:

    • Treated or untreated hypertension defined as blood pressure (BP)
    • 130 mmHg >= 85 mmHg (systolic / diastolic).
    • Waist circumference > 88 cm (35 inches) for women or > 102 cm (40 inches) for men.
    • Fasting glucose defined as >= 100 mg/dL but <= 125 mg/dL.
  • Subject has, in the opinion of the investigator, a life expectancy greater than 6 months.
  • Female subjects must have a negative pregnancy test prior to study enrollment.
  • Female subjects of child bearing potential must agree to practice an effective barrier method of birth control for the duration of the study.
  • Subject must be willing to observe the Step I Diet recommended by the NCEP throughout the study.
  • Subject must be willing to participate in the study and to complete all follow-up assessments.

Exclusion Criteria:

  • Subject has a known hypersensitivity to fenofibrate, ezetimibe, or atorvastatin
  • Subject has been previously enrolled in this study.
  • Subject has used an investigational drug within 30 days of study entry.
  • Subject has been diagnosed with Type I or Type II Diabetes Mellitus or is currently being treated with anti-diabetic medication, or has a fasting glucose >= 126 mg/dL.
  • Subject has a history of pancreatitis or cholelithiasis or a history of gastric or duodenal ulcer within 3 months of study entry.
  • Subject has hematologic, digestive, or central nervous system disorder including cerebrovascular disease or degenerative disease that would limit study evaluation or participation.
  • Subject has had a myocardial infarction, coronary bypass surgery, or angioplasty within 6 months of study entry.
  • Subject has unstable or severe peripheral artery disease within 3 months of study entry.
  • Subject has unstable angina pectoris or uncontrolled cardiac arrhythmias.
  • Subject has congestive heart failure (CHF) as defined by NYHA Class III or IV
  • Subject has coagulopathy (PT or PTT > 1.25 times control).
  • Subject has known impairment of renal function (serum creatinine > 1.5 mg/dL), dysproteinemia, nephrotic-range proteinuria, or other renal disease.
  • Subject has active or chronic hepatobiliary or hepatic disease (subjects with AST or ALT > 2 times the upper limit of the central laboratory reference range).
  • Subject is pregnant or lactating.
  • Subject is receiving hormonal therapy.
  • Subject has a known history of thyroid disease or other endocrine abnormality.
  • Subject has a history of diagnosed hereditary or acquired myopathy.
  • Subject is known to be HIV positive.
  • Subject has a history of mental instability, drug or alcohol (as defined by greater than 14 drinks per week) abuse, or subject has been treated for severe psychiatric illness, which, in the opinion of the investigator, may interfere with optimal participation in the study.
  • Subject has received a solid organ transplant.
  • Subject has a clinically significant, unstable, uncontrolled disease that could be adversely affected by study participation.
  • Subject is unwilling or unable to consent to enter the study.
  • Subject is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00195793

Sponsors and Collaborators
Abbott
Investigators
Study Director: Global Medical Information Abbott
  More Information

No publications provided

Study ID Numbers: M03-661
Study First Received: September 14, 2005
Last Updated: October 2, 2007
ClinicalTrials.gov Identifier: NCT00195793     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Hyperlipidemia
fenofibrate
ezetimibe
atorvastatin

Additional relevant MeSH terms:
Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Ezetimibe
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Procetofen
Pharmacologic Actions
Therapeutic Uses
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010