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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LCP-AtorFen

LCP-AtorFen 40/100mg fixed-dose combination tablet of 40mg atorvastatin and 145mg fenofibrate for treatment of mixed dyslipidemia

Group Type EXPERIMENTAL

LCP-AtorFen

Intervention Type DRUG

40mg atorvastatin combined with 100mg fenofibrate in a tablet for once daily treatment of dyslipidemia and mixed dyslipidemia

atorvastatin

atorvastatin 40mg tablet (Lipitor), as an adjunct to diet and exercise for treatment of mixed dyslipidemia

Group Type ACTIVE_COMPARATOR

atorvastatin

Intervention Type DRUG

dyslipidemia and mixed dyslipidemia

fenofibrate

fenofibrate 145mg tablet (Tricor), as an adjunct to diet and exercise for treatment of mixed dyslipidemia

Group Type ACTIVE_COMPARATOR

fenofibrate

Intervention Type DRUG

dyslipidemia and mixed dyslipidemia

Interventions

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LCP-AtorFen

40mg atorvastatin combined with 100mg fenofibrate in a tablet for once daily treatment of dyslipidemia and mixed dyslipidemia

Intervention Type DRUG

atorvastatin

dyslipidemia and mixed dyslipidemia

Intervention Type DRUG

fenofibrate

dyslipidemia and mixed dyslipidemia

Intervention Type DRUG

Other Intervention Names

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Lipitor Tricor

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No