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

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
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 :	February 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; LCP-AtorFen	Drug: LCP-AtorFen; anti-dyslipidemia
Active Comparator: 2; atorvastatin	Drug: atorvastatin; anti-dyslipidemia
Active Comparator: 3; fenofibrate	Drug: fenofibrate; anti-dyslipidemia

Outcome Measures

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Primary Outcome Measures :

1. The primary objectives of the study are to assess the non-HDL cholesterol and triglyceride lowering efficacy as well as the HDL cholesterol increasing efficacy of LCP AtorFen versus atorvastatin. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. The secondary objectives of the study are to assess the non-HDL and LDL cholesterol lowering efficacy as well as the HDL cholesterol increasing efficacy of LCP-AtorFen versus fenofibrate. [ Time Frame: 12 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Illinois
Radiant Research, 515 N State Street, Suite 2700
Chicago, Illinois, United States, 60610

Sponsors and Collaborators

Veloxis Pharmaceuticals

Investigators

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Davidson MH, Rooney MW, Drucker J, Eugene Griffin H, Oosman S, Beckert M; LCP-AtorFen Investigators. Efficacy and tolerability of atorvastatin/fenofibrate fixed-dose combination tablet compared with atorvastatin and fenofibrate monotherapies in patients with dyslipidemia: a 12-week, multicenter, double-blind, randomized, parallel-group study. Clin Ther. 2009 Dec;31(12):2824-38. doi: 10.1016/j.clinthera.2009.12.007.

ClinicalTrials.gov Identifier:	NCT00504829 History of Changes
Other Study ID Numbers:	LCP-AtorFen-2001
First Posted:	July 20, 2007
Last Update Posted:	April 15, 2008
Last Verified:	April 2008

Keywords provided by Veloxis Pharmaceuticals:

LCP-AtorFen; Non-HDL cholesterol; Triglycerides; HDL cholesterol	LDL cholesterol; Atorvastatin; Fenofibrate

Additional relevant MeSH terms:

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Atorvastatin Calcium; Fenofibrate; Anticholesteremic Agents	Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors