Efficacy of Fluvastatin and Fenofibrate in Comparison to Simvastatin and Ezetimibe in Patients With Metabolic Syndrome

A 16-week Multicenter, 2-period Study to Investigate the Effect of the Combination of Fluvastatin ER 80mg and Fenofibrate 200mg on HDL-C in Comparison to the Combination of Simvastatin 20mg and Ezetimibe 10mg in Patients With Metabolic Syndrome

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00385658

Enrollment

Registered

2006-10-11

Start date

2006-08-31

Completion date

2007-03-31

Last updated

2017-02-24

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

Conditions

Dyslipidemia

Keywords

Dyslipidemia, metabolic syndrome, fluvastatin, fenofibrate, simvastatin, ezetimibe

Brief summary

This study will investigate the effects of the combination of fluvastatin and fenofibrate on dyslipidemia in comparison to the combination of simvastatin and ezetimibe.

Interventions

DRUGFluvastatin extended release, fenofibrate

DRUGFixed combination simvastatin/ezetimibe

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Inclusion criteria

* Written informed consent to participate in the study prior to any study procedures. * Male or female subjects, age between 18-75 years inclusive. * All women of child bearing potential must have a negative pregnancy test * Metabolic Syndrome according to the International Diabetes Federation definition: * Low plasma HDL-C (Men \< 40 mg/dl ; Women \< 50 mg/dl ). * Elevated waist circumference (men ≥ 94 cm, women ≥ 80cm) * And one or more of the following criteria: * Triglycerides ≥ 150 mg/d.l * Raised blood pressure (DBP ≥ 85 mmHg and/or SBP ≥ 130mmHg ) or treated hypertension. * Fasting plasma glucose≥ 100mg/dl. * Previously diagnosed type 2 diabetes.

Exclusion criteria

* Dyslipidemia secondary to other causes such as nephrotic syndrome, autoimmune disease. * Type 1 diabetes. * HbA1c \> 9.5%. * Unexplained serum creatine phosphokinase \> 2 x Upper limit of normal. * History of myocardial infarction and/or cerebral stroke and/or unstable angina pectoris. * Known or suspected contraindications and warnings according to the country specific label for the investigational drugs. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
High density lipoprotein cholesterol (HDL-C) measured at the end of each study period.	—

Secondary

Measure	Time frame
patients reaching target levels of low density lipoprotein cholesterol (LDL-C) <100mg/dl	—
patients reaching target levels of non-HDL-C <130mg/	—
Compared at the end of each treatment period:	—
Triglycerides	—
LDL subfractions in a subgroup of patients	—
LDL-C/HDL-C	—

Countries

Germany, Switzerland

Outcome results

None listed

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