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

Phase 4

Completed

• Conditions: Dyslipidemia

• Registration Number: NCT00385658
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-10-10
• Study First Submitted QC: 2006-10-10
• Study First Posted: 2006-10-11
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
High density lipoprotein cholesterol (HDL-C) measured at the end of each study period.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novartis Pharma AG; 🇨🇭 Basel, Switzerland