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

February 22, 2017 updated by: Novartis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Investigative Centers, Germany
  • Switzerland
      • Basel, Switzerland
        • Novartis Pharma AG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Triglycerides
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
LDL subfractions in a subgroup of patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Director: Novartis Pharma AG, Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

October 10, 2006

First Submitted That Met QC Criteria

October 10, 2006

First Posted (Estimate)

October 11, 2006

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CXUO320BDE35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dyslipidemia

Clinical Trials on Fluvastatin extended release, fenofibrate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe