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

Hyperlipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349375
• Other study ID #: C LF0242780-01 05 01
• Secondary ID: 2005-003270-14
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2006
• Last updated: July 7, 2009
• Start date: November 2005
• Est. completion date: September 2008

Study information

• Verified date: July 2009
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesDenmark: Danish Medicines AgencyHungary: National Institute of PharmacyUkraine: Ministry of HealthCzech Republic: State Institute for Drug ControlPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsNetherlands: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1040
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• Fenofibrate/Simvastatin
Combination of Fenofibrate 145mg and Simvastatin 20mg
• Fenofibrate/Simvastatin
Combination of Fenofibrate and Simvastatin 40 mg
• Simvastatin
Simvastatin 40 mg

Locations

Country	Name	City	State
Czech Republic	Site 008	Brno
Czech Republic	Site 009	Brno
Czech Republic	Site 010	Brno
Czech Republic	Site 015	Hradisk
Czech Republic	Site 019	Karlovy Vary
Czech Republic	Site 014	Kladno
Czech Republic	Site 005	Nymburk
Czech Republic	Site 012	Olomouc
Czech Republic	Site 013	Olomouc
Czech Republic	Site 007	Plzen
Czech Republic	Site 018	Plzen
Czech Republic	Site 001	Prague
Czech Republic	Site 002	Prague
Czech Republic	Site 003	Prague
Czech Republic	Site 004	Prague
Czech Republic	Site 016	Pribram
Czech Republic	Site 017	Pribram
Czech Republic	Site 011	Slany
Czech Republic	Site 006	Tabor
Denmark	Site 201	Copenhagen
Denmark	Site 205	Copenhagen
Denmark	Site 203	Hvidovre
France	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	Murs-Erigne
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 Conde
France	Site 313	Vihiers
France	Site 320	Vue
Germany	Site 109	Deidesheim
Germany	Site 108	Frankfurt
Germany	Site 101	Freiburg
Germany	Site 111	Hamburg
Germany	Site 103	Hannover
Germany	Site 104	Ilvesheim
Germany	Site 110	Kassel
Germany	Site 106	Mannheim
Germany	Site 114	Munchen
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
Hungary	Site 406	Bekescsaba
Hungary	Site 401	Budapest
Hungary	Site 411	Budapest
Hungary	Site 412	Budapest
Hungary	Site 405	Debrecen
Hungary	Site 402	Gyongyos
Hungary	Site 409	Gyula
Hungary	Site 410	Kecskemet
Hungary	Site 404	Miskolc
Hungary	Site 413	Mosonmagyarovar
Hungary	Site 407	Oroshaza
Hungary	Site 408	Szeged
Hungary	Site 403	Szolnok
Netherlands	Site 508	Breda
Netherlands	Site 509	De Bilt
Netherlands	Site 511	Den Bosch
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
Poland	Site 606	Chrzanow
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
Ukraine	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	Kharkov
Ukraine	Site 704	Kyiv
Ukraine	Site 706	Kyiv
Ukraine	Site 707	Kyiv
Ukraine	Site 708	Kyiv
Ukraine	Site 715	Kyiv
Ukraine	Site 713	Lugansk
Ukraine	Site 714	Odessa
Ukraine	Site 710	Zaporizhya

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

Czech Republic,  Denmark,  France,  Germany,  Hungary,  Netherlands,  Poland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline to 24 weeks of treatment in Triglycerides		12 weeks	No
Primary	Percent change from baseline to 24 weeks of treatment in HDL-C		12 weeks	No
Primary	Percent change from baseline to 24 weeks of treatment in LDL-C		12 weeks	No
Secondary	Percent change from baseline to 24 weeks of treatment in Triglycerides		24 weeks	No
Secondary	Percent change from baseline to 24 weeks of treatment in HDL-C		24 weeks	No
Secondary	Percent change from baseline to 24 weeks of treatment in LDL-C		24 weeks	No