Clinical trial NCT00349375: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Keywords: Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-07-07
Enrollment: 1040
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent change from baseline to 24 weeks of treatment in Triglycerides
timeFrame: 12 weeks
measure: Percent change from baseline to 24 weeks of treatment in HDL-C
timeFrame: 12 weeks
measure: Percent change from baseline to 24 weeks of treatment in LDL-C
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent change from baseline to 24 weeks of treatment in Triglycerides
timeFrame: 24 weeks
measure: Percent change from baseline to 24 weeks of treatment in HDL-C
timeFrame: 24 weeks
measure: Percent change from baseline to 24 weeks of treatment in LDL-C
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Site 008
city: Brno
country: Czech Republic
facility: Site 009
city: Brno
country: Czech Republic
facility: Site 010
city: Hradisk
country: Czech Republic
facility: Site 015
city: Karlovy Vary
country: Czech Republic
facility: Site 019
city: Kladno
country: Czech Republic
facility: Site 014
city: Nymburk
country: Czech Republic
facility: Site 005
city: Olomouc
country: Czech Republic
facility: Site 012
city: Olomouc
country: Czech Republic
facility: Site 013
city: Plzen
country: Czech Republic
facility: Site 007
city: Plzeň
country: Czech Republic
facility: Site 018
city: Prague
country: Czech Republic
facility: Site 001
city: Prague
country: Czech Republic
facility: Site 002
city: Prague
country: Czech Republic
facility: Site 003
city: Prague
country: Czech Republic
facility: Site 004
city: Pribram
country: Czech Republic
facility: Site 016
city: Pribram
country: Czech Republic
facility: Site 017
city: Slany
country: Czech Republic
facility: Site 011
city: Tabor
country: Czech Republic
facility: Site 006
city: Copenhagen
country: Denmark
facility: Site 201
city: Copenhagen
country: Denmark
facility: Site 205
city: Hvidovre
country: Denmark
facility: Site 203
city: Bouliac
country: France
facility: Site 302
city: Briollay
country: France
facility: Site 314
city: Corsept
country: France
facility: Site 318
city: Dijon
country: France
facility: Site 301
city: La Montagne
country: France
facility: Site 317
city: Le mesnil en Valee
country: France
facility: Site 321
city: Loudon
country: France
facility: Site 316
city: Mont de Marsan
country: France
facility: Site 308
city: Murs-Erigne
country: France
facility: Site 312
city: Nantes
country: France
facility: Site 310
city: Niort
country: France
facility: Site 304
city: Orvault
country: France
facility: Site 319
city: Paris
country: France
facility: Site 306
city: Pouilly en Auxois
country: France
facility: Site 305
city: Rouen
country: France
facility: Site 307
city: Rouen
country: France
facility: Site 311
city: Saint Justin
country: France
facility: Site 303
city: Thouars
country: France
facility: Site 315
city: Vieux Conde
country: France
facility: Site 309
city: Vihiers
country: France
facility: Site 313
city: Vue
country: France
facility: Site 320
city: Deidesheim
country: Germany
facility: Site 109
city: Frankfurt
country: Germany
facility: Site 108
city: Freiburg
country: Germany
facility: Site 101
city: Hamburg
country: Germany
facility: Site 111
city: Hannover
country: Germany
facility: Site 103
city: Ilvesheim
country: Germany
facility: Site 104
city: Kassel
country: Germany
facility: Site 110
city: Mannheim
country: Germany
facility: Site 106
city: Munchen
country: Germany
facility: Site 114
city: Neu-Anspach
country: Germany
facility: Site 113
city: Offenbach
country: Germany
facility: Site 105
city: Offenbach
country: Germany
facility: Site 107
city: Paderborn Kernstadt
country: Germany
facility: Site 115
city: Rodgau
country: Germany
facility: Site 102
city: Wermsdorf
country: Germany
facility: Site 112
city: Bekescsaba
country: Hungary
facility: Site 406
city: Budapest
country: Hungary
facility: Site 401
city: Budapest
country: Hungary
facility: Site 411
city: Budapest
country: Hungary
facility: Site 412
city: Debrecen
country: Hungary
facility: Site 405
city: Gyongyos
country: Hungary
facility: Site 402
city: Gyula
country: Hungary
facility: Site 409
city: Kecskemet
country: Hungary
facility: Site 410
city: Miskolc
country: Hungary
facility: Site 404
city: Mosonmagyarovar
country: Hungary
facility: Site 413
city: Oroshaza
country: Hungary
facility: Site 407
city: Szeged
country: Hungary
facility: Site 408
city: Szolnok
country: Hungary
facility: Site 403
city: Breda
country: Netherlands
facility: Site 508
city: De Bilt
country: Netherlands
facility: Site 509
city: Den Bosch
country: Netherlands
facility: Site 511
city: Eindhoven
country: Netherlands
facility: Site 502
city: Eindhoven
country: Netherlands
facility: Site 514
city: Groningen
country: Netherlands
facility: Site 503
city: Hengelo
country: Netherlands
facility: Site 512
city: Leiden
country: Netherlands
facility: Site 506
city: Nijmegen
country: Netherlands
facility: Site 507
city: Rotterdam
country: Netherlands
facility: Site 501
city: Tiel
country: Netherlands
facility: Site 513
city: Utrecht
country: Netherlands
facility: Site 510
city: Velp
country: Netherlands
facility: Site 505
city: Zoetermeer
country: Netherlands
facility: Site 504
city: Chrzanow
country: Poland
facility: Site 606
city: Gdansk
country: Poland
facility: Site 601
city: Katowice
country: Poland
facility: Site 603
city: Sopot
country: Poland
facility: Site 609
city: Warsaw
country: Poland
facility: Site 602
city: Warsaw
country: Poland
facility: Site 607
city: Warsaw
country: Poland
facility: Site 608
city: Wroclaw
country: Poland
facility: Site 605
city: Wroclaw
country: Poland
facility: Site 610
city: Zabrze
country: Poland
facility: Site 604
city: Dnipropetrovsk
country: Ukraine
facility: Site 701
city: Dnipropetrovsk
country: Ukraine
facility: Site 702
city: Dnipropetrovsk
country: Ukraine
facility: Site 709
city: Donetsk
country: Ukraine
facility: Site 712
city: Kharkiv
country: Ukraine
facility: Site 703
city: Kharkiv
country: Ukraine
facility: Site 705
city: Kharkov
country: Ukraine
facility: Site 711
city: Kyiv
country: Ukraine
facility: Site 704
city: Kyiv
country: Ukraine
facility: Site 706
city: Kyiv
country: Ukraine
facility: Site 707
city: Kyiv
country: Ukraine
facility: Site 708
city: Kyiv
country: Ukraine
facility: Site 715
city: Lugansk
country: Ukraine
facility: Site 713
city: Odessa
country: Ukraine
facility: Site 714
city: Zaporizhya
country: Ukraine
facility: Site 710
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: