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

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fenofibrate/Simvastatin
Fenofibrate/Simvastatin
Simvastatin
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site 008
  • Site 009
  • Site 010
  • Site 015
  • Site 019
  • Site 014
  • Site 005
  • Site 012
  • Site 013
  • Site 007
  • Site 018
  • Site 001
  • Site 002
  • Site 003
  • Site 004
  • Site 016
  • Site 017
  • Site 011
  • Site 006
  • Site 201
  • Site 205
  • Site 203
  • Site 302
  • Site 314
  • Site 318
  • Site 301
  • Site 317
  • Site 321
  • Site 316
  • Site 308
  • Site 312
  • Site 310
  • Site 304
  • Site 319
  • Site 306
  • Site 305
  • Site 307
  • Site 311
  • Site 303
  • Site 315
  • Site 309
  • Site 313
  • Site 320
  • Site 109
  • Site 108
  • Site 101
  • Site 111
  • Site 103
  • Site 104
  • Site 110
  • Site 106
  • Site 114
  • Site 113
  • Site 105
  • Site 107
  • Site 115
  • Site 102
  • Site 112
  • Site 406
  • Site 401
  • Site 411
  • Site 412
  • Site 405
  • Site 402
  • Site 409
  • Site 410
  • Site 404
  • Site 413
  • Site 407
  • Site 408
  • Site 403
  • Site 508
  • Site 509
  • Site 511
  • Site 502
  • Site 514
  • Site 503
  • Site 512
  • Site 506
  • Site 507
  • Site 501
  • Site 513
  • Site 510
  • Site 505
  • Site 504
  • Site 606
  • Site 601
  • Site 603
  • Site 609
  • Site 602
  • Site 607
  • Site 608
  • Site 605
  • Site 610
  • Site 604
  • Site 701
  • Site 702
  • Site 709
  • Site 712
  • Site 703
  • Site 705
  • Site 711
  • Site 704
  • Site 706
  • Site 707
  • Site 708
  • Site 715
  • Site 713
  • Site 714
  • Site 710

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Percent change from baseline to 24 weeks of treatment in Triglycerides
Percent change from baseline to 24 weeks of treatment in HDL-C
Percent change from baseline to 24 weeks of treatment in LDL-C

Secondary Outcome Measures

Percent change from baseline to 24 weeks of treatment in Triglycerides
Percent change from baseline to 24 weeks of treatment in HDL-C
Percent change from baseline to 24 weeks of treatment in LDL-C

Full Information

First Posted
July 6, 2006
Last Updated
July 7, 2009
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00349375
Brief Title
Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1040 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fenofibrate/Simvastatin
Intervention Description
Combination of Fenofibrate 145mg and Simvastatin 20mg
Intervention Type
Drug
Intervention Name(s)
Fenofibrate/Simvastatin
Intervention Description
Combination of Fenofibrate and Simvastatin 40 mg
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
Simvastatin 40 mg
Primary Outcome Measure Information:
Title
Percent change from baseline to 24 weeks of treatment in Triglycerides
Time Frame
12 weeks
Title
Percent change from baseline to 24 weeks of treatment in HDL-C
Time Frame
12 weeks
Title
Percent change from baseline to 24 weeks of treatment in LDL-C
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percent change from baseline to 24 weeks of treatment in Triglycerides
Time Frame
24 weeks
Title
Percent change from baseline to 24 weeks of treatment in HDL-C
Time Frame
24 weeks
Title
Percent change from baseline to 24 weeks of treatment in LDL-C
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 008
City
Brno
Country
Czech Republic
Facility Name
Site 009
City
Brno
Country
Czech Republic
Facility Name
Site 010
City
Brno
Country
Czech Republic
Facility Name
Site 015
City
Hradisk
Country
Czech Republic
Facility Name
Site 019
City
Karlovy Vary
Country
Czech Republic
Facility Name
Site 014
City
Kladno
Country
Czech Republic
Facility Name
Site 005
City
Nymburk
Country
Czech Republic
Facility Name
Site 012
City
Olomouc
Country
Czech Republic
Facility Name
Site 013
City
Olomouc
Country
Czech Republic
Facility Name
Site 007
City
Plzen
Country
Czech Republic
Facility Name
Site 018
City
Plzeň
Country
Czech Republic
Facility Name
Site 001
City
Prague
Country
Czech Republic
Facility Name
Site 002
City
Prague
Country
Czech Republic
Facility Name
Site 003
City
Prague
Country
Czech Republic
Facility Name
Site 004
City
Prague
Country
Czech Republic
Facility Name
Site 016
City
Pribram
Country
Czech Republic
Facility Name
Site 017
City
Pribram
Country
Czech Republic
Facility Name
Site 011
City
Slany
Country
Czech Republic
Facility Name
Site 006
City
Tabor
Country
Czech Republic
Facility Name
Site 201
City
Copenhagen
Country
Denmark
Facility Name
Site 205
City
Copenhagen
Country
Denmark
Facility Name
Site 203
City
Hvidovre
Country
Denmark
Facility Name
Site 302
City
Bouliac
Country
France
Facility Name
Site 314
City
Briollay
Country
France
Facility Name
Site 318
City
Corsept
Country
France
Facility Name
Site 301
City
Dijon
Country
France
Facility Name
Site 317
City
La Montagne
Country
France
Facility Name
Site 321
City
Le mesnil en Valee
Country
France
Facility Name
Site 316
City
Loudon
Country
France
Facility Name
Site 308
City
Mont de Marsan
Country
France
Facility Name
Site 312
City
Murs-Erigne
Country
France
Facility Name
Site 310
City
Nantes
Country
France
Facility Name
Site 304
City
Niort
Country
France
Facility Name
Site 319
City
Orvault
Country
France
Facility Name
Site 306
City
Paris
Country
France
Facility Name
Site 305
City
Pouilly en Auxois
Country
France
Facility Name
Site 307
City
Rouen
Country
France
Facility Name
Site 311
City
Rouen
Country
France
Facility Name
Site 303
City
Saint Justin
Country
France
Facility Name
Site 315
City
Thouars
Country
France
Facility Name
Site 309
City
Vieux Conde
Country
France
Facility Name
Site 313
City
Vihiers
Country
France
Facility Name
Site 320
City
Vue
Country
France
Facility Name
Site 109
City
Deidesheim
Country
Germany
Facility Name
Site 108
City
Frankfurt
Country
Germany
Facility Name
Site 101
City
Freiburg
Country
Germany
Facility Name
Site 111
City
Hamburg
Country
Germany
Facility Name
Site 103
City
Hannover
Country
Germany
Facility Name
Site 104
City
Ilvesheim
Country
Germany
Facility Name
Site 110
City
Kassel
Country
Germany
Facility Name
Site 106
City
Mannheim
Country
Germany
Facility Name
Site 114
City
Munchen
Country
Germany
Facility Name
Site 113
City
Neu-Anspach
Country
Germany
Facility Name
Site 105
City
Offenbach
Country
Germany
Facility Name
Site 107
City
Offenbach
Country
Germany
Facility Name
Site 115
City
Paderborn Kernstadt
Country
Germany
Facility Name
Site 102
City
Rodgau
Country
Germany
Facility Name
Site 112
City
Wermsdorf
Country
Germany
Facility Name
Site 406
City
Bekescsaba
Country
Hungary
Facility Name
Site 401
City
Budapest
Country
Hungary
Facility Name
Site 411
City
Budapest
Country
Hungary
Facility Name
Site 412
City
Budapest
Country
Hungary
Facility Name
Site 405
City
Debrecen
Country
Hungary
Facility Name
Site 402
City
Gyongyos
Country
Hungary
Facility Name
Site 409
City
Gyula
Country
Hungary
Facility Name
Site 410
City
Kecskemet
Country
Hungary
Facility Name
Site 404
City
Miskolc
Country
Hungary
Facility Name
Site 413
City
Mosonmagyarovar
Country
Hungary
Facility Name
Site 407
City
Oroshaza
Country
Hungary
Facility Name
Site 408
City
Szeged
Country
Hungary
Facility Name
Site 403
City
Szolnok
Country
Hungary
Facility Name
Site 508
City
Breda
Country
Netherlands
Facility Name
Site 509
City
De Bilt
Country
Netherlands
Facility Name
Site 511
City
Den Bosch
Country
Netherlands
Facility Name
Site 502
City
Eindhoven
Country
Netherlands
Facility Name
Site 514
City
Eindhoven
Country
Netherlands
Facility Name
Site 503
City
Groningen
Country
Netherlands
Facility Name
Site 512
City
Hengelo
Country
Netherlands
Facility Name
Site 506
City
Leiden
Country
Netherlands
Facility Name
Site 507
City
Nijmegen
Country
Netherlands
Facility Name
Site 501
City
Rotterdam
Country
Netherlands
Facility Name
Site 513
City
Tiel
Country
Netherlands
Facility Name
Site 510
City
Utrecht
Country
Netherlands
Facility Name
Site 505
City
Velp
Country
Netherlands
Facility Name
Site 504
City
Zoetermeer
Country
Netherlands
Facility Name
Site 606
City
Chrzanow
Country
Poland
Facility Name
Site 601
City
Gdansk
Country
Poland
Facility Name
Site 603
City
Katowice
Country
Poland
Facility Name
Site 609
City
Sopot
Country
Poland
Facility Name
Site 602
City
Warsaw
Country
Poland
Facility Name
Site 607
City
Warsaw
Country
Poland
Facility Name
Site 608
City
Warsaw
Country
Poland
Facility Name
Site 605
City
Wroclaw
Country
Poland
Facility Name
Site 610
City
Wroclaw
Country
Poland
Facility Name
Site 604
City
Zabrze
Country
Poland
Facility Name
Site 701
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Site 702
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Site 709
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Site 712
City
Donetsk
Country
Ukraine
Facility Name
Site 703
City
Kharkiv
Country
Ukraine
Facility Name
Site 705
City
Kharkiv
Country
Ukraine
Facility Name
Site 711
City
Kharkov
Country
Ukraine
Facility Name
Site 704
City
Kyiv
Country
Ukraine
Facility Name
Site 706
City
Kyiv
Country
Ukraine
Facility Name
Site 707
City
Kyiv
Country
Ukraine
Facility Name
Site 708
City
Kyiv
Country
Ukraine
Facility Name
Site 715
City
Kyiv
Country
Ukraine
Facility Name
Site 713
City
Lugansk
Country
Ukraine
Facility Name
Site 714
City
Odessa
Country
Ukraine
Facility Name
Site 710
City
Zaporizhya
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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