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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

NCT01674712 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 575

Last updated 2014-12-11

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Jean-Claude Ansquer, MD · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Argentina
  • Czechia
  • Germany
  • Mexico
  • Poland
  • Romania
  • Russia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01674712 on ClinicalTrials.gov