Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy
NCT ID: NCT00349375
Last Updated: 2009-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1040 participants
INTERVENTIONAL
2005-11-30
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Fenofibrate/Simvastatin
Combination of Fenofibrate 145mg and Simvastatin 20mg
2
Fenofibrate/Simvastatin
Combination of Fenofibrate and Simvastatin 40 mg
3
Simvastatin
Simvastatin 40 mg
Interventions
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Fenofibrate/Simvastatin
Combination of Fenofibrate 145mg and Simvastatin 20mg
Fenofibrate/Simvastatin
Combination of Fenofibrate and Simvastatin 40 mg
Simvastatin
Simvastatin 40 mg
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant or lactating women
* Contra-indication to fenofibrate or simvastatin
* Unstable or severe cardiac disease
18 Years
75 Years
ALL
No
Sponsors
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Solvay Pharmaceuticals
INDUSTRY
Responsible Party
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Solvay Pharmaceuticals
Principal Investigators
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Global Clinical Director Solvay
Role: STUDY_DIRECTOR
Solvay Pharmaceuticals
Locations
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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
Countries
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Other Identifiers
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2005-003270-14
Identifier Type: -
Identifier Source: secondary_id
C LF0242780-01 05 01
Identifier Type: -
Identifier Source: org_study_id
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