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

Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385658
• Other study ID #: CXUO320BDE35
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2006
• Last updated: February 22, 2017
• Start date: August 2006
• Est. completion date: March 2007

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Metabolic Syndrome X

Intervention

Drug:
• Fluvastatin extended release, fenofibrate

• Fixed combination simvastatin/ezetimibe

Locations

Country	Name	City	State
Switzerland	Novartis Pharma AG	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High density lipoprotein cholesterol (HDL-C) measured at the end of each study period.
Secondary	Compared at the end of each treatment period:
Secondary	patients reaching target levels of low density lipoprotein cholesterol (LDL-C) <100mg/dl
Secondary	patients reaching target levels of non-HDL-C <130mg/
Secondary	LDL-C/HDL-C
Secondary	Triglycerides
Secondary	LDL subfractions in a subgroup of patients

External Links

•   Results of study CXUO320BDE35 from the Novartis Clinical Trials website