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

19:07 EDT 23rd April 2014 | BioPortfolio

Summary

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

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

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Dyslipidemia

Intervention

LCP-AtorFen, atorvastatin, fenofibrate

Location

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

Status

Completed

Source

LifeCycle Pharma A/S

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

An antilipemic agent which reduces both CHOLESTEROL and TRIGLYCERIDES in the blood.

A cluster of metabolic risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components of metabolic syndrome X include excess ABDOMINAL FAT; atherogenic DYSLIPIDEMIA; HYPERTENSION; HYPERGLYCEMIA; INSULIN RESISTANCE; a proinflammatory state; and a prothrombotic (THROMBOSIS) state. (from AHA/NHLBI/ADA Conference Proceedings, Circulation 2004; 109:551-556)

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PubMed Articles [256 Associated PubMed Articles listed on BioPortfolio]

Efficacy and Safety of Alternate Day Therapy With Atorvastatin and Fenofibrate Combination in Mixed Dyslipidemia: A Randomized Controlled Trial.

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Atherogenic dyslipidemia and combination pharmacotherapy in diabetes: recent clinical trials.

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HMGB1 Is Involved in the Protective Effect of the PPAR α Agonist Fenofibrate against Cardiac Hypertrophy.

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