Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy - Full Text View

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00349375

Purpose

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.

Condition	Intervention	Phase
Hyperlipidemia	Drug: Fenofibrate/Simvastatin Drug: Simvastatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Procetofen Simvastatin

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Percent change from baseline to 24 weeks of treatment in Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline to 24 weeks of treatment in HDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline to 24 weeks of treatment in LDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change from baseline to 24 weeks of treatment in Triglycerides [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Percent change from baseline to 24 weeks of treatment in HDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Percent change from baseline to 24 weeks of treatment in LDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	1040
Study Start Date:	November 2005
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Fenofibrate/Simvastatin Combination of Fenofibrate 145mg and Simvastatin 20mg
2: Experimental	Drug: Fenofibrate/Simvastatin Combination of Fenofibrate and Simvastatin 40 mg
3: Active Comparator	Drug: Simvastatin Simvastatin 40 mg

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349375

Hide Study Locations

Locations

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

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Martine Guy )
Study ID Numbers:	C LF0242780-01 05 01, 2005-003270-14
Study First Received:	July 6, 2006
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00349375 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Denmark: Danish Medicines Agency; Hungary: National Institute of Pharmacy; Ukraine: Ministry of Health; Czech Republic: State Institute for Drug Control; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Netherlands: Ministry of Health

Keywords provided by Solvay Pharmaceuticals:

Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Procetofen
Pharmacologic Actions
Therapeutic Uses
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 22, 2009