A 16 Week Comparative Study of Fenofibrate Versus Ezetimibe as Add-on Therapy to Atorvastatin

NCT00195793 | Completed Phase 3

• 1 other identifier: M03-661
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hyperlipidemia

Keywords

Hyperlipidemia; fenofibrate; ezetimibe; atorvastatin

Outcome Measures

Primary Outcomes (1)

• Percent change from Combination Baseline to 12 weeks post-Combination Baseline in direct measured HDL-C and TG.

  Week 12

Secondary Outcomes (1)

• Advanced lipid and inflammatory parameters

  Week 12

Interventions

fenofibrate DRUG

ezetimibe DRUG

atorvastatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Fenofibrate; Ezetimibe; Atorvastatin

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Global Medical Information

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 20, 2005
• Study Start: August 1, 2004
• Last Updated: October 4, 2007

Record last verified: 2007-10