Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy

A Multicenter, Double-Blind, Randomized, Active Comparator, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With 40 mg Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 20 mg Simvastatin Alone

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00349375

Enrollment

1040

Registered

2006-07-07

Start date

2005-11-30

Completion date

2008-09-30

Last updated

2009-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia

Keywords

Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin

Brief summary

Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Interventions

DRUGFenofibrate/Simvastatin

Combination of Fenofibrate 145mg and Simvastatin 20mg

DRUGSimvastatin

Simvastatin 40 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Mixed dyslipidemia

Exclusion criteria

* Known hypersensitivity to fenofibrate or simvastatin * Pregnant or lactating women * Contra-indication to fenofibrate or simvastatin * Unstable or severe cardiac disease

Design outcomes

Primary

Measure	Time frame
Percent change from baseline to 24 weeks of treatment in Triglycerides	12 weeks
Percent change from baseline to 24 weeks of treatment in HDL-C	12 weeks
Percent change from baseline to 24 weeks of treatment in LDL-C	12 weeks

Secondary

Measure	Time frame
Percent change from baseline to 24 weeks of treatment in Triglycerides	24 weeks
Percent change from baseline to 24 weeks of treatment in HDL-C	24 weeks
Percent change from baseline to 24 weeks of treatment in LDL-C	24 weeks

Countries

Czechia, Denmark, France, Germany, Hungary, Netherlands, Poland, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026