A Controlled-Study of Fenofibrate 145 mg and Ezetimibe 10 mg in Type IIb Dyslipidemic Patients With Features of the Metabolic Syndrome

August 31, 2007 updated by: Solvay Pharmaceuticals

A Randomised, Double-Blind Study Comparing the Efficacy and Safety of 145 mg Fenofibrate, 10 mg Ezetimibe and Their Combination in Patients With Type IIb Dyslipidemia and Features of the Metabolic Syndrome

Type IIb dyslipidemia is characterized by elevated triglycerides (TG ³ 150 mg/dL), and elevated LDL-C levels (³160 mg/dL). When in addition, HDL-C is low, the presence of the lipid triad, elevated TG and LDL-C and low levels of HDL-C, seems to confer additional CHD risk in this type of patient, compared to elevated LDL-C alone.Coadministration of fenofibrate and ezetimibe could provide a complementary efficacy therapy and improve the atherogenic profile of this patient population.

Study Overview

Status

Completed

Conditions

Hyperlipidemia Combined

Intervention / Treatment

Drug: Combination of 145 mg fenofibrate and 10 mg ezetimibe

Study Type

Interventional

Enrollment

181

Phase

Phase 3

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

Belgium
- - Charleroi, Belgium
    - Site 113
  - Couillet, Belgium
    - Site 112
  - Dessel, Belgium
    - Site 115
  - Dour, Belgium
    - Site 114
  - Genk, Belgium
    - Site 106
  - Genly, Belgium
    - Site 102
  - Komen, Belgium
    - Site 111
  - Kortessem, Belgium
    - Site 109
  - Kortrijk, Belgium
    - Site 104
  - Luik, Belgium
    - Site 108
  - Menen, Belgium
    - Site 107
  - Moen, Belgium
    - Site 105
  - Oosteeklo, Belgium
    - Site 101
  - Oostham, Belgium
    - Site 110
  - Seraing, Belgium
    - Site 116
  - Turnhout, Belgium
    - Site 103
France
- - Bondy, France
    - Site 213
  - Le Beausset, France
    - Site 211
  - Nantes, France
    - Site 209
  - Orvault, France
    - Site 202
  - Paris, France
    - Site 206
  - Paris, France
    - Site 208
  - Paris Cedex, France
    - Site 212
  - Saint Cyr, France
    - Site 203
  - Six Fours les Plages, France
    - Site 210
  - St Sébastian sur Loire, France
    - Site 201
  - St Sébastian sur Loire, France
    - Site 205
  - St Sébastian sur Loire, France
    - Site 207
  - Toulon, France
    - Site 204
Germany
- - Borna, Germany
    - Site 313
  - Bretten, Germany
    - Site 307
  - Dresden, Germany
    - Site 306
  - Erbach, Germany
    - Site 305
  - Frankfurt, Germany
    - Site 304
  - Frankfurt, Germany
    - Site 308
  - Frankfurt, Germany
    - Site 311
  - Ilvesheim, Germany
    - Site 301
  - Leipzig, Germany
    - Site 302
  - Leipzig, Germany
    - Site 303
  - Mannheim, Germany
    - Site 314
  - Offenbach, Germany
    - Site 309
  - Offenbach, Germany
    - Site 312
  - Rodgau, Germany
    - Site 310

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Type IIb dyslipidemia.

Exclusion Criteria:

Known hypersensitivity to fibrates or ezetimibe. Pregnant or lactating women. Contra-indication to fenofibrate or ezetimibe.

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: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
TG and HDL-C levels.

Collaborators and Investigators

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

Sponsor

Solvay Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Ansquer JC, Bekaert I, Guy M, Hanefeld M, Simon A; Study Investigators. Efficacy and safety of coadministration of fenofibrate and ezetimibe compared with each as monotherapy in patients with type IIb dyslipidemia and features of the metabolic syndrome: a prospective, randomized, double-blind, three-parallel arm, multicenter, comparative study. Am J Cardiovasc Drugs. 2009;9(2):91-101. doi: 10.1007/BF03256580.

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

January 1, 2005

Study Registration Dates

First Submitted

July 5, 2006

First Submitted That Met QC Criteria

July 5, 2006

First Posted (Estimate)

July 6, 2006

Study Record Updates

Last Update Posted (Estimate)

September 3, 2007

Last Update Submitted That Met QC Criteria

August 31, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Hyperlipidemia Combined and features of the metabolic syndrome, efficacy combination fenofibrate ezetimibe

Additional Relevant MeSH Terms

Other Study ID Numbers

C LF 178P 04 01
2004-002408-13

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.