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

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
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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
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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
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Drug: fenofibrate
dyslipidemia and mixed dyslipidemia
Other Name: Tricor |
- 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.
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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).
- 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.
- Other inclusion criteria might apply
Exclusion Criteria:
- TGs > 500 mg/dL.
- History of coronary heart disease (CHD), transient ischemic attacks, stroke or revascularization procedure in the six months prior.
- Presence of an aortic aneurysm or resection of an aortic aneurysm within six months.
- Poorly controlled diabetes mellitus (glycosylated hemoglobin >8.0% )or diabetes mellitus requiring insulin therapy.
- Known lipoprotein lipase impairment or deficiency or Apo C-II deficiency or familial dysbetalipoproteinemia.
- History of pancreatitis.
- Known allergy or sensitivity to statins or fibrates.
- Poorly controlled hypertension.
- Other exclusion criteria might apply.

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
United States, Illinois | |
Radiant Research, 515 N State Street, Suite 2700 | |
Chicago, Illinois, United States, 60610 |
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. |
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 |
LCP-AtorFen Non-HDL cholesterol Triglycerides HDL cholesterol |
LDL cholesterol Atorvastatin Fenofibrate |
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 |