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Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia

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ClinicalTrials.gov Identifier: NCT00504829
Recruitment Status : Completed
First Posted : July 20, 2007
Results First Posted : February 5, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Veloxis Pharmaceuticals

Study Description
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Brief Summary:
The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a combination of atorvastatin and fenofibrate.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: LCP-AtorFen Drug: atorvastatin Drug: fenofibrate Phase 2

Detailed Description:

This is a multicenter, randomized, double-blind, 12 week study with a 52-week open-label follow-up to evaluate the safety and efficacy of LCP-AtorFen (the combination of atorvastatin and fenofibrate) in the treatment of hyperlipidemia.

After a wash-out phase, eligible patients will be randomized on a 1:1:1 ratio to either LCP-AtorFen, atorvastatin or fenofibrate for 12 weeks. After the completion of the 12-week phase, all eligible patients will be offered to receive open-label LCP-AtorFen for another 52 weeks.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 12-Week, Multi-Center, Double-Blind, Randomized, Parallel-Group Study, Followed by a 12 Month Extension Study, of the Efficacy and Safety of LCP-AtorFen in Subjects With Dyslipidemia
Study Start Date : July 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LCP-AtorFen
LCP-AtorFen 40/100mg fixed-dose combination tablet of 40mg atorvastatin and 145mg fenofibrate for treatment of mixed dyslipidemia
 Drug: LCP-AtorFen
40mg atorvastatin combined with 100mg fenofibrate in a tablet for once daily treatment of dyslipidemia and mixed dyslipidemia
Active Comparator: atorvastatin
atorvastatin 40mg tablet (Lipitor), as an adjunct to diet and exercise for treatment of mixed dyslipidemia
 Drug: atorvastatin
dyslipidemia and mixed dyslipidemia
Other Name: Lipitor
Active Comparator: fenofibrate
fenofibrate 145mg tablet (Tricor), as an adjunct to diet and exercise for treatment of mixed dyslipidemia
 Drug: fenofibrate
dyslipidemia and mixed dyslipidemia
Other Name: Tricor


Outcome Measures
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Primary Outcome Measures :
  1. Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy [ Time Frame: baseline(randomization) to 12 weeks ]
    Mean percent change from baseline to end-of-treatment (12 weeks) for non-HDL cholesterol and triglycerides and the mean percent change from baseline to end-of-treatment for HDL cholesterol for AtorFen 40/100mg fixed-dose combination tablet versus atorvastatin 40mg tablet.


Secondary Outcome Measures :
  1. Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy [ Time Frame: baseline (week 0) to 12 weeks ]
    Mean percent changes from baseline (Visit 3, Week 0) to end-of-treatment (Visit 6; Week 12) in non-HDL, HDL and LDL cholesterol by LCP-AtorFen versus fenofibrate monotherapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A diagnosis of dyslipidemia (non-HDL-C >130 mg/dL and Triglycerides > or equal to 150 mg/dL and < or equal to 500 mg/dL).
  2. Subject may be currently on a statin or other lipid-lowering therapy but must be willing and able to washout for 8 weeks if on a fibrate or high-dose niacin, 6 weeks if on a statin or low-dose niacin per day, or 4 weeks if on a bile acid sequestrant, ezetimibe, or >1000 mg of fish oil per day.
  3. Other inclusion criteria might apply

Exclusion Criteria:

  1. TGs > 500 mg/dL.
  2. History of coronary heart disease (CHD), transient ischemic attacks, stroke or revascularization procedure in the six months prior.
  3. Presence of an aortic aneurysm or resection of an aortic aneurysm within six months.
  4. Poorly controlled diabetes mellitus (glycosylated hemoglobin >8.0% )or diabetes mellitus requiring insulin therapy.
  5. Known lipoprotein lipase impairment or deficiency or Apo C-II deficiency or familial dysbetalipoproteinemia.
  6. History of pancreatitis.
  7. Known allergy or sensitivity to statins or fibrates.
  8. Poorly controlled hypertension.
  9. Other exclusion criteria might apply.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504829


Locations
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United States, Illinois
Radiant Research, 515 N State Street, Suite 2700
Chicago, Illinois, United States, 60610
Sponsors and Collaborators
Veloxis Pharmaceuticals
Investigators
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Principal Investigator: Jeff Geohas, MD Radiant Research
Study Director: Dennis McCluskey, MD Radiant Research
Study Director: Harry Geisberg, MD Radiant Research
Study Director: Chivers Woodruff, Jr, MD Radiant Research
Study Director: Michael Noss, MD Radiant Research
Study Director: Michele Reynolds, MD Radiant Research
Study Director: James Zavoral, MD Radiant Research
Study Director: Randall Severance, MD Radiant Research
Study Director: Stephen Halpern, MD Radiant Research
Study Director: Linda Murray, MD Radiant Research
Study Director: Wayne Larson, MD Radiant Research
Study Director: Timothy Howards, MD Medical Affiliated Research Center, Inc.
Study Director: Cynthia Strout, MD Coastal Carolina Research Center
Study Director: Mark Kipnes, MD Diabetes and Glandular Research Center, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00504829    
Other Study ID Numbers: LCP-AtorFen-2001
First Posted: July 20, 2007    Key Record Dates
Results First Posted: February 5, 2020
Last Update Posted: February 17, 2020
Last Verified: February 2020
Keywords provided by Veloxis Pharmaceuticals:
LCP-AtorFen
Non-HDL cholesterol
Triglycerides
HDL cholesterol
 LDL cholesterol
Atorvastatin
Fenofibrate
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Fenofibrate
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors