Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy
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
2 other identifiers
interventional
1,040
8 countries
110
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2005
Typical duration for phase_3
110 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 6, 2006
CompletedFirst Posted
Study publicly available on registry
July 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedJuly 8, 2009
July 1, 2009
2.8 years
July 6, 2006
July 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percent change from baseline to 24 weeks of treatment in Triglycerides
12 weeks
Percent change from baseline to 24 weeks of treatment in HDL-C
12 weeks
Percent change from baseline to 24 weeks of treatment in LDL-C
12 weeks
Secondary Outcomes (3)
Percent change from baseline to 24 weeks of treatment in Triglycerides
24 weeks
Percent change from baseline to 24 weeks of treatment in HDL-C
24 weeks
Percent change from baseline to 24 weeks of treatment in LDL-C
24 weeks
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Mixed dyslipidemia
You may not qualify if:
- Known hypersensitivity to fenofibrate or simvastatin
- Pregnant or lactating women
- Contra-indication to fenofibrate or simvastatin
- Unstable or severe cardiac disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (110)
Site 008
Brno, Czechia
Site 009
Brno, Czechia
Site 010
Brno, Czechia
Site 015
Hradisk, Czechia
Site 019
Karlovy Vary, Czechia
Site 014
Kladno, Czechia
Site 005
Nymburk, Czechia
Site 012
Olomouc, Czechia
Site 013
Olomouc, Czechia
Site 007
Pilsen, Czechia
Site 018
Pilsen, Czechia
Site 001
Prague, Czechia
Site 002
Prague, Czechia
Site 003
Prague, Czechia
Site 004
Prague, Czechia
Site 016
Příbram, Czechia
Site 017
Příbram, Czechia
Site 011
Slaný, Czechia
Site 006
Tábor, Czechia
Site 201
Copenhagen, Denmark
Site 205
Copenhagen, Denmark
Site 203
Hvidovre, Denmark
Site 302
Bouliac, France
Site 314
Briollay, France
Site 318
Corsept, France
Site 301
Dijon, France
Site 317
La Montagne, France
Site 321
Le Mesnil En Valee, France
Site 316
Loudon, France
Site 308
Mont-de-Marsan, France
Site 312
Mûrs-Erigné, France
Site 310
Nantes, France
Site 304
Niort, France
Site 319
Orvault, France
Site 306
Paris, France
Site 305
Pouilly-en-Auxois, France
Site 307
Rouen, France
Site 311
Rouen, France
Site 303
Saint-Justin, France
Site 315
Thouars, France
Site 309
Vieux-Condé, France
Site 313
Vihiers, France
Site 320
Vue, France
Site 109
Deidesheim, Germany
Site 108
Frankfurt, Germany
Site 101
Freiburg im Breisgau, Germany
Site 111
Hamburg, Germany
Site 103
Hanover, Germany
Site 104
Ilvesheim, Germany
Site 110
Kassel, Germany
Site 106
Mannheim, Germany
Site 114
München, Germany
Site 113
Neu-Anspach, Germany
Site 105
Offenbach, Germany
Site 107
Offenbach, Germany
Site 115
Paderborn Kernstadt, Germany
Site 102
Rodgau, Germany
Site 112
Wermsdorf, Germany
Site 406
Békéscsaba, Hungary
Site 401
Budapest, Hungary
Site 411
Budapest, Hungary
Site 412
Budapest, Hungary
Site 405
Debrecen, Hungary
Site 402
Gyöngyös, Hungary
Site 409
Gyula, Hungary
Site 410
Kecskemét, Hungary
Site 404
Miskolc, Hungary
Site 413
Mosonmagyaróvár, Hungary
Site 407
Orosháza, Hungary
Site 408
Szeged, Hungary
Site 403
Szolnok, Hungary
Site 511
's-Hertogenbosch, Netherlands
Site 508
Breda, Netherlands
Site 509
De Bilt, Netherlands
Site 502
Eindhoven, Netherlands
Site 514
Eindhoven, Netherlands
Site 503
Groningen, Netherlands
Site 512
Hengelo, Netherlands
Site 506
Leiden, Netherlands
Site 507
Nijmegen, Netherlands
Site 501
Rotterdam, Netherlands
Site 513
Tiel, Netherlands
Site 510
Utrecht, Netherlands
Site 505
Velp, Netherlands
Site 504
Zoetermeer, Netherlands
Site 606
Chrzanów, Poland
Site 601
Gdansk, Poland
Site 603
Katowice, Poland
Site 609
Sopot, Poland
Site 602
Warsaw, Poland
Site 607
Warsaw, Poland
Site 608
Warsaw, Poland
Site 605
Wroclaw, Poland
Site 610
Wroclaw, Poland
Site 604
Zabrze, Poland
Site 701
Dnipropetrovsk, Ukraine
Site 702
Dnipropetrovsk, Ukraine
Site 709
Dnipropetrovsk, Ukraine
Site 712
Donetsk, Ukraine
Site 703
Kharkiv, Ukraine
Site 705
Kharkiv, Ukraine
Site 711
Kharkiv, Ukraine
Site 704
Kyiv, Ukraine
Site 706
Kyiv, Ukraine
Site 707
Kyiv, Ukraine
Site 708
Kyiv, Ukraine
Site 715
Kyiv, Ukraine
Site 713
Luhansk, Ukraine
Site 714
Odesa, Ukraine
Site 710
Zaporizhya, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 6, 2006
First Posted
July 7, 2006
Study Start
November 1, 2005
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
July 8, 2009
Record last verified: 2009-07