Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin

July 7, 2009 updated by: Solvay Pharmaceuticals

A Multicenter, Double-Blind, Randomized, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With Atorvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 10 mg Atorvastatin 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 compare the efficacy and safety of combining fenofibrate and simvastatin versus atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

516

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

  • Bulgaria
      • Haskovo, Bulgaria
        • Site 501
      • Pleven, Bulgaria
        • Site 505
      • Plovdiv, Bulgaria
        • Site 503
      • Plovdiv, Bulgaria
        • Site 506
      • Sofia, Bulgaria
        • Site 500
      • Sofia, Bulgaria
        • Site 502
      • Sofia, Bulgaria
        • Site 504
      • Sofia, Bulgaria
        • Site 507
      • Sofia, Bulgaria
        • Site 509
      • Sofia, Bulgaria
        • Site 511
      • Varna, Bulgaria
        • Site 508
      • Varna, Bulgaria
        • Site 510
  • Czech Republic
      • Chrudim, Czech Republic
        • Site 109
      • Havirov, Czech Republic
        • Site 117
      • Olomouc, Czech Republic
        • Site 101
      • Olomouc, Czech Republic
        • Site 114
      • Ostrava, Czech Republic
        • Site 116
      • Pardubice, Czech Republic
        • Site 107
      • Pardubice, Czech Republic
        • Site 111
      • Plzen, Czech Republic
        • Site 113
      • Praha, Czech Republic
        • Site 115
      • Praha 1, Czech Republic
        • Site 108
      • Praha 2, Czech Republic
        • Site 100
      • Praha 5, Czech Republic
        • Site 104
      • Praha 6, Czech Republic
        • Site 110
      • Teplice, Czech Republic
        • Site 103
      • Trutnov, Czech Republic
        • Site 106
      • Unicov, Czech Republic
        • Site 118
      • Usti nad Orlici, Czech Republic
        • Site 102
  • Germany
      • Berlin, Germany
        • Site 203
      • Bochum, Germany
        • Site 204
      • Dresden, Germany
        • Site 205
      • Gorlitz, Germany
        • Site 206
      • Hamburg, Germany
        • Site 202
      • Karlsruhe, Germany
        • Site 208
      • Leipzig, Germany
        • Site 207
      • Magdeburg, Germany
        • Site 201
      • Nuernberg, Germany
        • Site 209
      • Unterschneidheim, Germany
        • Site 200
  • Slovakia
      • Banska Bystrica, Slovakia
        • Site 301
      • Bratislava, Slovakia
        • Site 307
      • Bratislava, Slovakia
        • Site 310
      • Bratislava, Slovakia
        • Site 311
      • Bratislava, Slovakia
        • Site 312
      • Dolny kubin, Slovakia
        • Site 309
      • Kosice, Slovakia
        • Site 302
      • Lucenec, Slovakia
        • Site 305
      • Nitra, Slovakia
        • Site 306
      • Nove Zamky, Slovakia
        • Site 304
      • Presov, Slovakia
        • Site 308
      • Vrable, Slovakia
        • Site 303
      • Zilina, Slovakia
        • Site 300
  • Ukraine
      • Donetsk, Ukraine
        • Site 416
      • Kharkov, Ukraine
        • Site 401
      • Kiev, Ukraine
        • Site 412
      • Kyiv, Ukraine
        • Site 402
      • Kyiv, Ukraine
        • Site 404
      • Kyiv, Ukraine
        • Site 408
      • Kyiv, Ukraine
        • Site 410
      • Lutsk, Ukraine
        • Site 414
      • Lviv, Ukraine
        • Site 406
      • Odessa, Ukraine
        • Site 407
      • Odessa, Ukraine
        • Site 409
      • Odessa, Ukraine
        • Site 411
      • Simferopol, Ukraine
        • Site 405
      • Uzhorod, Ukraine
        • Site 413
      • Vinnitsa, Ukraine
        • Site 400
      • Zaporozhye, Ukraine
        • Site 415

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 fenofibrates or simvastatin or atorvastatin
  • Pregnant or lactating women
  • Contra-indication to fenofibrate or simvastatin or atorvastatin
  • 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
ACTIVE_COMPARATOR: 2
Drug: Atorvastatin
Atorvastatin 10 mg and 20mg
EXPERIMENTAL: 1
Drug: fenofibrate / simvastatin
Combination of fenofibrate and simvastatin 20 mg and 40 mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

October 1, 2006

Primary Completion (ACTUAL)

August 1, 2008

Study Completion (ACTUAL)

August 1, 2008

Study Registration Dates

First Submitted

August 11, 2006

First Submitted That Met QC Criteria

August 11, 2006

First Posted (ESTIMATE)

August 15, 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 03
  • 2006-000519-21

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.

Subscribe