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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Fluvastatin extended release, fenofibrate

Intervention Type DRUG

Fixed combination simvastatin/ezetimibe

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No