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

Information source: Solvay Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiovascular Diseases

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

Phase: Phase 3

Status: Completed

Sponsored by: Solvay Pharmaceuticals

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

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.

Clinical Details

Official title: A Multicenter, Double-Blind, Randomized Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 40 mg Simvastatin With 40 mg Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 40 mg Simvastatin Alone.

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

Primary outcome:

Triglycerides

Percent change from baseline to 12 weeks of treatment in HDL-C

Percent change from baseline to 12 weeks of treatment in LDL-C

Secondary outcome:

Percent change from baseline to 24 weeks of treatment in Triglycerides

Percent change from baseline to 24 weeks of treatment in HDL-C

Percent change from baseline to 24 weeks of treatment in LDL-C

Eligibility

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

Criteria:

Inclusion Criteria:

- Mixed dyslipidemia

Exclusion Criteria:

- Diabetes,

- Known hypersensitivity to fenofibrate or simvastatin,

- Pregnant or lactating women,

- Contra-indication to fenofibrate or simvastatin,

- Unstable or severe cardiac disease.

Locations and Contacts

Site 204, Adelaide, Australia

Site 214, Adelaide, Australia

Site 203, Bendigo, Australia

Site 207, Brisbane, Australia

Site 208, Brisbane, Australia

Site 221, Brisbane, Australia

Site 202, Burnie, Australia

Site 201, Camperdown, Australia

Site 220, Coffs Harbour, Australia

Site 218, Daw Park, Australia

Site 212, Elizabeth Vale, Australia

Site 217, Fitzroy, Australia

Site 222, Fremantle, Australia

Site 216, Geelong, Australia

Site 225, Ingleburn, Australia

Site 213, Kippa-ring, Australia

Site 209, Launceston, Australia

Site 219, Liverpool, Australia

Site 223, Malvern, Australia

Site 211, Meadowbrook, Australia

Site 224, Miranda, Australia

Site 210, Nambour, Australia

Site 205, Parkville, Australia

Site 206, Sale, Australia

Site 215, Sydney, Australia

Site 301, Tallinn, Estonia

Site 302, Tallinn, Estonia

Site 303, Tallinn, Estonia

Site 305, Tallinn, Estonia

Site 306, Tallinn, Estonia

Site 304, Tartu, Estonia

Site 307, Tartu, Estonia

Site 603, Balatonfured, Hungary

Site 605, Budapest, Hungary

Site 608, Budapest, Hungary

Site 604, Gyongyos, Hungary

Site 602, Gyor, Hungary

Site 610, Hodmezovasarhely, Hungary

Site 609, Kecskemet, Hungary

Site 601, Miskolc, Hungary

Site 607, Sopron, Hungary

Site 606, Szekesfehervar, Hungary

Site 403, Daugavpils, Latvia

Site 406, Jekabpils, Latvia

Site 401, Ogre, Latvia

Site 402, Riga, Latvia

Site 405, Riga, Latvia

Site 404, Tukums, Latvia

Site 502, Alytus, Lithuania

Site 503, Kaunas, Lithuania

Site 506, Kaunas, Lithuania

Site 505, Klaipeda, Lithuania

Site 507, Klaipeda, Lithuania

Site 508, Palanga, Lithuania

Site 504, Siauliai, Lithuania

Site 501, Vilnius, Lithuania

Site 102, Auckland, New Zealand

Site 103, Auckland, New Zealand

Site 107, Blenheim, New Zealand

Site 101, Christchurch, New Zealand

Site 108, Dunedin, New Zealand

Site 104, Hamilton, New Zealand

Site 111, Hastings, New Zealand

Site 106, Nelson, New Zealand

Site 110, Newtown, Wellington, New Zealand

Site 109, Takapuna, Auckland, New Zealand

Site 105, Tauranga, New Zealand

Additional Information

Starting date: January 2006
Last updated: July 7, 2009

Page last updated: August 23, 2015

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