Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy

July 7, 2009 updated by: Solvay Pharmaceuticals

A Multicenter, Double-Blind, Randomized, Active Comparator, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With 40 mg Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 20 mg Simvastatin Alone

Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1040

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

  • Czech Republic
      • Brno, Czech Republic
        • Site 008
      • Brno, Czech Republic
        • Site 009
      • Brno, Czech Republic
        • Site 010
      • Hradisk, Czech Republic
        • Site 015
      • Karlovy Vary, Czech Republic
        • Site 019
      • Kladno, Czech Republic
        • Site 014
      • Nymburk, Czech Republic
        • Site 005
      • Olomouc, Czech Republic
        • Site 012
      • Olomouc, Czech Republic
        • Site 013
      • Plzen, Czech Republic
        • Site 007
      • Plzeň, Czech Republic
        • SITE 018
      • Prague, Czech Republic
        • Site 001
      • Prague, Czech Republic
        • Site 002
      • Prague, Czech Republic
        • Site 003
      • Prague, Czech Republic
        • Site 004
      • Pribram, Czech Republic
        • Site 016
      • Pribram, Czech Republic
        • SITE 017
      • Slany, Czech Republic
        • Site 011
      • Tabor, Czech Republic
        • Site 006
  • Denmark
      • Copenhagen, Denmark
        • Site 201
      • Copenhagen, Denmark
        • Site 205
      • Hvidovre, Denmark
        • Site 203
  • France
      • Bouliac, France
        • Site 302
      • Briollay, France
        • Site 314
      • Corsept, France
        • Site 318
      • Dijon, France
        • Site 301
      • La Montagne, France
        • Site 317
      • Le mesnil en Valee, France
        • Site 321
      • Loudon, France
        • Site 316
      • Mont de Marsan, France
        • Site 308
      • Murs-Erigne, France
        • Site 312
      • Nantes, France
        • Site 310
      • Niort, France
        • Site 304
      • Orvault, France
        • Site 319
      • Paris, France
        • Site 306
      • Pouilly en Auxois, France
        • Site 305
      • Rouen, France
        • Site 307
      • Rouen, France
        • Site 311
      • Saint Justin, France
        • Site 303
      • Thouars, France
        • Site 315
      • Vieux Conde, France
        • Site 309
      • Vihiers, France
        • Site 313
      • Vue, France
        • Site 320
  • Germany
      • Deidesheim, Germany
        • Site 109
      • Frankfurt, Germany
        • Site 108
      • Freiburg, Germany
        • Site 101
      • Hamburg, Germany
        • Site 111
      • Hannover, Germany
        • Site 103
      • Ilvesheim, Germany
        • SITE 104
      • Kassel, Germany
        • Site 110
      • Mannheim, Germany
        • Site 106
      • Munchen, Germany
        • Site 114
      • Neu-Anspach, Germany
        • Site 113
      • Offenbach, Germany
        • Site 105
      • Offenbach, Germany
        • Site 107
      • Paderborn Kernstadt, Germany
        • Site 115
      • Rodgau, Germany
        • Site 102
      • Wermsdorf, Germany
        • Site 112
  • Hungary
      • Bekescsaba, Hungary
        • Site 406
      • Budapest, Hungary
        • Site 401
      • Budapest, Hungary
        • Site 411
      • Budapest, Hungary
        • Site 412
      • Debrecen, Hungary
        • Site 405
      • Gyongyos, Hungary
        • Site 402
      • Gyula, Hungary
        • Site 409
      • Kecskemet, Hungary
        • Site 410
      • Miskolc, Hungary
        • Site 404
      • Mosonmagyarovar, Hungary
        • Site 413
      • Oroshaza, Hungary
        • Site 407
      • Szeged, Hungary
        • Site 408
      • Szolnok, Hungary
        • Site 403
  • Netherlands
      • Breda, Netherlands
        • Site 508
      • De Bilt, Netherlands
        • Site 509
      • Den Bosch, Netherlands
        • Site 511
      • Eindhoven, Netherlands
        • Site 502
      • Eindhoven, Netherlands
        • Site 514
      • Groningen, Netherlands
        • Site 503
      • Hengelo, Netherlands
        • Site 512
      • Leiden, Netherlands
        • Site 506
      • Nijmegen, Netherlands
        • Site 507
      • Rotterdam, Netherlands
        • Site 501
      • Tiel, Netherlands
        • Site 513
      • Utrecht, Netherlands
        • Site 510
      • Velp, Netherlands
        • Site 505
      • Zoetermeer, Netherlands
        • Site 504
  • Poland
      • Chrzanow, Poland
        • Site 606
      • Gdansk, Poland
        • Site 601
      • Katowice, Poland
        • Site 603
      • Sopot, Poland
        • Site 609
      • Warsaw, Poland
        • Site 602
      • Warsaw, Poland
        • Site 607
      • Warsaw, Poland
        • Site 608
      • Wroclaw, Poland
        • Site 605
      • Wroclaw, Poland
        • Site 610
      • Zabrze, Poland
        • Site 604
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Site 701
      • Dnipropetrovsk, Ukraine
        • Site 702
      • Dnipropetrovsk, Ukraine
        • Site 709
      • Donetsk, Ukraine
        • Site 712
      • Kharkiv, Ukraine
        • Site 703
      • Kharkiv, Ukraine
        • Site 705
      • Kharkov, Ukraine
        • Site 711
      • Kyiv, Ukraine
        • Site 704
      • Kyiv, Ukraine
        • Site 706
      • Kyiv, Ukraine
        • Site 707
      • Kyiv, Ukraine
        • Site 708
      • Kyiv, Ukraine
        • Site 715
      • Lugansk, Ukraine
        • Site 713
      • Odessa, Ukraine
        • Site 714
      • Zaporizhya, Ukraine
        • Site 710

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mixed dyslipidemia

Exclusion Criteria:

  • Known hypersensitivity to fenofibrate or simvastatin
  • Pregnant or lactating women
  • Contra-indication to fenofibrate or simvastatin
  • Unstable or severe cardiac disease

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: Fenofibrate/Simvastatin
Combination of Fenofibrate and Simvastatin 40 mg
Drug: Fenofibrate/Simvastatin
Combination of Fenofibrate 145mg and Simvastatin 20mg
EXPERIMENTAL: 2
Drug: Fenofibrate/Simvastatin
Combination of Fenofibrate and Simvastatin 40 mg
Drug: Fenofibrate/Simvastatin
Combination of Fenofibrate 145mg and Simvastatin 20mg
ACTIVE_COMPARATOR: 3
Drug: Simvastatin
Simvastatin 40 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline to 24 weeks of treatment in Triglycerides
Time Frame: 12 weeks
12 weeks
Percent change from baseline to 24 weeks of treatment in HDL-C
Time Frame: 12 weeks
12 weeks
Percent change from baseline to 24 weeks of treatment in LDL-C
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline to 24 weeks of treatment in Triglycerides
Time Frame: 24 weeks
24 weeks
Percent change from baseline to 24 weeks of treatment in HDL-C
Time Frame: 24 weeks
24 weeks
Percent change from baseline to 24 weeks of treatment in LDL-C
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

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

Sponsor

Solvay Pharmaceuticals

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

November 1, 2005

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

July 6, 2006

First Submitted That Met QC Criteria

July 6, 2006

First Posted (ESTIMATE)

July 7, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 8, 2009

Last Update Submitted That Met QC Criteria

July 7, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C LF0242780-01 05 01
  • 2005-003270-14

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.

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