NCT01674712

A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease

A 12-week, Double-blind, Randomized Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate / Simvastatin 145/20mg and Fenofibrate / Simvastatin 145/40mg Tablets vs. Matching Monotherapies in Dyslipidemic Subjects at High Risk of Cardiovascular Disease.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 575 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, randomized study designed to compare the efficacy and safety of two fixed combinations of fenofibrate / simvastatin 145/20 mg and fenofibrate / simvastatin 145/40 mg tablets vs. matching monotherapies in subjects with abnormal fat (lipids) in the blood and at high risk of cardiovascular disease. Fenofibrate is a treatment that lowers fat in blood. It is prescribed in patients with high levels of triglycerides (TG). The drug has been marketed in more than 80 countries since 1975. Simvastatin is also used for the treatment of patients with a high level of cholesterol. These have also been marketed worldwide for more than 20 years. It is important to treat high levels of fats in the blood because it has been shown that even mildly elevated level of lipids in the blood can lead to diseases of the blood vessels. It has been shown in several studies and in clinical practice that the combination of fenofibrate plus simvastatin can lead to improved effects on blood fats, compared to treatment with simvastatin or fenofibrate alone. The main objective of the study is to compare the efficacy of the two fixed-combinations (FC) -fenofibrate/simvastatin 145/20 mg tablet and fenofibrate/simvastatin 145/40 mg tablet in reducing TG and increasing high density lipoprotein cholesterol (HDL-C) versus simvastatin 20 mg or 40 mg, and in reducing low density lipoprotein cholesterol (LDL-C) versus fenofibrate 145 mg.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	Fixed Combination of Fenofibrate/simvastatin 145/20 mg	Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
DRUG	Simvastatin 20 mg	Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
DRUG	Fenofibrate 145 mg	Fenofibrate, tablet, 145 mg, once daily, 12 weeks
DRUG	Fixed Combination of Fenofibrate/simvastatin 145/40 mg	Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
DRUG	Simvastatin 40 mg	simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-08-29
• Last updated: 2014-12-11
• Results posted: 2014-10-30

Locations

69 sites across 7 countries: Argentina, Czechia, Germany, Mexico, Poland, Romania, Russia