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

This study has been completed.

First Received: October 10, 2006 Last Updated: March 20, 2008 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00385658

Purpose

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

Condition	Intervention	Phase
Dyslipidemia	Drug: Fluvastatin extended release, fenofibrate Drug: Fixed combination simvastatin/ezetimibe	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

Drug Information available for: Procetofen Simvastatin Fluvastatin Ezetimibe

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	70
Study Start Date:	August 2006

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385658

Locations

Germany

Investigative Centers, Germany
Switzerland
Novartis Pharma AG
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharma AG

Novartis

More Information

No publications provided

Study ID Numbers:	CXUO320BDE35
Study First Received:	October 10, 2006
Last Updated:	March 20, 2008
ClinicalTrials.gov Identifier:	NCT00385658 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Dyslipidemia
metabolic syndrome
fluvastatin

fenofibrate
simvastatin
ezetimibe

Additional relevant MeSH terms:

Antimetabolites
Disease
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors
Ezetimibe
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Procetofen
Pharmacologic Actions
Fluvastatin
Pathologic Processes
Therapeutic Uses
Syndrome
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010