Zolip 0501: Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy

Condition(s) targeted: Hyperlipidemia

Intervention: Fenofibrate/Simvastatin (Drug); Fenofibrate/Simvastatin (Drug); Simvastatin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

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.

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

Primary outcome: Percent change from baseline to 12 weeks of treatment in TG, HDL-C and LDL-C

Secondary outcome: Percent change from baseline in TG, HDL-C, LDL-C, non HDL-C, TC, Apo AI and Apo B; change from baseline in hs CRP and fibrinogen. Percentage of patients reaching the NCEP ATP III target LDL-C and TG levels.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

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 007, Plzen, 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 013, Olomouc, 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

Site 201, Copenhagen, Denmark

Site 203, Hvidovre, Denmark

Site 205, Copenhagen, Denmark

Site 301, Dijon, France

Site 302, Bouliac, France

Site 303, Saint Justin, France

Site 304, Niort, France

Site 305, Pouilly en Auxois, 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 313, Vihiers, France

Site 314, Briollay, France

Site 315, Thouars, France

Site 316, Loudon, France

Site 317, La Montagne, France

Site 318, Corsept, France

Site 319, Orvault, France

Site 320, Vue, France

Site 321, Le mesnil en Valee, France

Site 101, Freiburg, Germany

Site 102, Rodgau, Germany

Site 103, Hannover, Germany

Site 104, Ilvesheim, Germany

Site 105, Offenbach, Germany

Site 106, Mannheim, Germany

Site 107, Offenbach, Germany

Site 108, Frankfurt, Germany

Site 109, Deidesheim, Germany

Site 110, Kassel, Germany

Site 111, Hamburg, Germany

Site 112, Wermsdorf, Germany

Site 113, Neu-Anspach, Germany

Site 114, Munchen, Germany

Site 115, Paderborn Kernstadt, Germany

Site 401, Budapest, Hungary

Site 402, Gyongyos, Hungary

Site 403, Szolnok, Hungary

Site 404, Miskolc, Hungary

Site 405, Debrecen, Hungary

Site 406, Bekescsaba, Hungary

Site 407, Oroshaza, Hungary

Site 408, Szeged, Hungary

Site 409, Gyula, Hungary

Site 410, Kecskemet, Hungary

Site 411, Budapest, Hungary

Site 412, Budapest, Hungary

Site 413, Mosonmagyarovar, Hungary

Site 501, Rotterdam, Netherlands

Site 502, Eindhoven, Netherlands

Site 503, Groningen, Netherlands

Site 504, Zoetermeer, Netherlands

Site 505, Velp, Netherlands

Site 506, Leiden, Netherlands

Site 507, Nijmegen, Netherlands

Site 508, Breda, Netherlands

Site 509, De Bilt, Netherlands

Site 510, Utrecht, Netherlands

Site 511, Den Bosch, Netherlands

Site 512, Hengelo, Netherlands

Site 513, Tiel, Netherlands

Site 514, Eindhoven, Netherlands

Site 601, Gdansk, Poland

Site 602, Warsaw, Poland

Site 603, Katowice, Poland

Site 604, Zabrze, Poland

Site 605, Wroclaw, Poland

Site 606, Chrzanow, Poland

Site 607, Warsaw, Poland

Site 608, Warsaw, Poland

Site 609, Sopot, Poland

Site 610, Wroclaw, Poland

Site 701, Dnipropetrovsk, Ukraine

Site 702, Dnipropetrovsk, Ukraine

Site 703, Kharkiv, 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 715, Kyiv, Ukraine

Starting date: November 2005
Ending date: November 2008
Last updated: March 25, 2008