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

Novartis

Status and phase: Completed; Phase 4

Conditions: Dyslipidemia

Treatments: Drug: Fixed combination simvastatin/ezetimibe; Drug: Fluvastatin extended release, fenofibrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00385658

CXUO320BDE35

Details and patient eligibility

About

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

Enrollment: 75 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)