Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin

Hyperlipidemia Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With Atorvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 10 mg Atorvastatin Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362934
• Other study ID #: C LF0242780-01 05 03
• Secondary ID: 2006-000519-21
• Status: Completed
• Phase: Phase 3
• First received: August 11, 2006
• Last updated: July 7, 2009
• Start date: October 2006
• Est. completion date: August 2008

Study information

• Verified date: July 2009
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesCzech Republic: State Institute for Drug ControlSlovakia: State Institute for Drug ControlUkraine: State Pharmacological Center - 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 compare the efficacy and safety of combining fenofibrate and simvastatin versus atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Mixed dyslipidemia.

Exclusion Criteria:

• Known hypersensitivity to fenofibrates or simvastatin or atorvastatin

• Pregnant or lactating women

• Contra-indication to fenofibrate or simvastatin or atorvastatin

• 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 and simvastatin 20 mg and 40 mg
• Atorvastatin
Atorvastatin 10 mg and 20mg

Locations

Country	Name	City	State
Bulgaria	Site 501	Haskovo
Bulgaria	Site 505	Pleven
Bulgaria	Site 503	Plovdiv
Bulgaria	Site 506	Plovdiv
Bulgaria	Site 500	Sofia
Bulgaria	Site 502	Sofia
Bulgaria	Site 504	Sofia
Bulgaria	Site 507	Sofia
Bulgaria	Site 509	Sofia
Bulgaria	Site 511	Sofia
Bulgaria	Site 508	Varna
Bulgaria	Site 510	Varna
Czech Republic	Site 109	Chrudim
Czech Republic	Site 117	Havirov
Czech Republic	Site 101	Olomouc
Czech Republic	Site 114	Olomouc
Czech Republic	Site 116	Ostrava
Czech Republic	Site 107	Pardubice
Czech Republic	Site 111	Pardubice
Czech Republic	Site 113	Plzen
Czech Republic	Site 115	Praha
Czech Republic	Site 108	Praha 1
Czech Republic	Site 100	Praha 2
Czech Republic	Site 104	Praha 5
Czech Republic	Site 110	Praha 6
Czech Republic	Site 103	Teplice
Czech Republic	Site 106	Trutnov
Czech Republic	Site 118	Unicov
Czech Republic	Site 102	Usti nad Orlici
Germany	Site 203	Berlin
Germany	Site 204	Bochum
Germany	Site 205	Dresden
Germany	Site 206	Gorlitz
Germany	Site 202	Hamburg
Germany	Site 208	Karlsruhe
Germany	Site 207	Leipzig
Germany	Site 201	Magdeburg
Germany	Site 209	Nuernberg
Germany	Site 200	Unterschneidheim
Slovakia	Site 301	Banska Bystrica
Slovakia	Site 307	Bratislava
Slovakia	Site 310	Bratislava
Slovakia	Site 311	Bratislava
Slovakia	Site 312	Bratislava
Slovakia	Site 309	Dolny kubin
Slovakia	Site 302	Kosice
Slovakia	Site 305	Lucenec
Slovakia	Site 306	Nitra
Slovakia	Site 304	Nove Zamky
Slovakia	Site 308	Presov
Slovakia	Site 303	Vrable
Slovakia	Site 300	Zilina
Ukraine	Site 416	Donetsk
Ukraine	Site 401	Kharkov
Ukraine	Site 412	Kiev
Ukraine	Site 402	Kyiv
Ukraine	Site 404	Kyiv
Ukraine	Site 408	Kyiv
Ukraine	Site 410	Kyiv
Ukraine	Site 414	Lutsk
Ukraine	Site 406	Lviv
Ukraine	Site 407	Odessa
Ukraine	Site 409	Odessa
Ukraine	Site 411	Odessa
Ukraine	Site 405	Simferopol
Ukraine	Site 413	Uzhorod
Ukraine	Site 400	Vinnitsa
Ukraine	Site 415	Zaporozhye

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Germany,  Slovakia,  Ukraine, 

Outcome

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