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

11:20 EDT 25th October 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

Clinical Trials [323 Associated Clinical Trials listed on BioPortfolio]

12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia

The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia

Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes

The primary objective was to assess the effect of 3-month treatment of low and standard doses of fenofibrate in combination with stable dose of metformin on fasting triglycerides levels in...

Fenofibrate and Pharmacogenetic Impact in Dyslipidemia

The purpose of the study is to learn whether genetics plays a role in predicting response to a commonly used and FDA (Food and Drug Administration) approved medication for lowering triglyc...

Acceptability of a Fixed Combination of Fenofibrate and Metformin

The primary objective was to assess the acceptability of a 4-week treatment of 4 new fixed-dose combinations of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia...

Pharmacological Regulation of Fat Transport in Metabolic Syndrome

The purpose of this study is to determine whether atorvastatin and fenofibrate are effective in the treatment of lipid disorders in obese, insulin resistant subjects.

PubMed Articles [331 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.

Introduction:The long half-life of atorvastatin and fenofibrate makes them suitable for alternate day therapy. Hence, we aimed to study the efficacy, safety, and cost-effectiveness of alternate day th...

Fenofibrate Increases Serum Creatinine in a Patient with Familial Nephropathy Associated to Hyperuricemia.

Background: Kidney function progressively deteriorates in patients with familial juvenile hyperuricemiac nephropathy (FJHN, OMIN 162000) and chronic renal disease is commonly associated to dyslipidemi...

Alternate Day versus Once Daily Atorvastatin for Primary Prevention of (CHD) in Naïve Patients of Dyslipidemia.

Introduction: Statins (or HMG-CoA reductase inhibitors) have become drug of choice for raised Low-Density Lipoprotein Cholesterol (LDL-C) in treating. Of these, Atorvastatin, because of its prolonged ...

Suspicion of Fenofibrate-related Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Syndrome: a Case Report.

We describe a DRESS syndrome induced by fenofibrate. This side effect, rarely described with fenofibrate, should be known by clinicians to stop it immediately and avoid serious complications.

Comparison of low-dose rosuvastatin with atorvastatin in lipid-lowering efficacy and safety in a high-risk pakistani cohort: an open-label randomized trial.

Background. Treatment of hyperlipidemia is helpful in both primary and secondary prevention of coronary heart disease and stroke. Aim. To compare lipid-lowering efficacy of rosuvastatin with atorvasta...

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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