Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin

Phase 3

Completed

• Conditions: Hyperlipidemia
• Interventions: Drug: Fenofibrate/Simvastatin; Drug: Pravastatin

• Registration Number: NCT00362206
• Lead Sponsor: Solvay Pharmaceuticals

Brief 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 pravastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-08
• Study First Submitted QC: 2006-08-08
• Study First Posted: 2006-08-09
• Study Start: 2006-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-07
• Last Update Posted: 2009-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 423

Inclusion Criteria

• Mixed dyslipidemia

Exclusion Criteria

• Known hypersensitivity to fenofibrates or simvastatin or pravastatin
• Pregnant or lactating women
• Contra-indication to fenofibrate or simvastatin or pravastatin
• Unstable or severe cardiac disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Fenofibrate/Simvastatin	-
2	Fenofibrate/Simvastatin	-
3	Pravastatin	-

Primary Outcome Measures

Name	Time	Method
Percent change from baseline to 12 weeks of treatment in Triglycerides	12 weeks
Percent change from baseline to 12 weeks of treatment in HDL-C	12 weeks
Percent change from baseline to 12 weeks of treatment in LDL-C	12 weeks

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline to 12 weeks of treatment in Triglycerides	24 weeks
Percent change from baseline to 12 weeks of treatment in HDL-C	24 weeks
Percent change from baseline to 12 weeks of treatment in LDL-C	24 weeks

Trial Locations

Locations (41)

Site 40; 🇬🇷 Athens, Greece

Site 5; 🇷🇴 Arad, Romania

Site 7; 🇷🇴 Bacau, Romania

Site 4; 🇷🇴 Oradea, Romania

Site 3; 🇷🇴 Ploiesti, Romania

Site 2; 🇷🇴 Targu Mures, Romania

Site 39; 🇬🇷 Ioannina, Greece

Site 41; 🇬🇷 Thessaloniki, Greece

Site 1; 🇷🇴 Bucuresti, Romania

Site 37; 🇮🇱 Beer Yaakov, Israel

Site 6; 🇷🇴 Cluj-Napoca, Romania

Site 23; 🇮🇱 Tel-Aviv, Israel

Site 19; 🇮🇱 Haifa, Israel

Site 38; 🇮🇱 Kfar Saba, Israel

Site 22; 🇮🇱 Holon, Israel

Site 20; 🇮🇱 Rechovot, Israel

Site 21; 🇮🇱 Ramat Gan, Israel

Site 17; 🇮🇱 Ramat Gan, Israel

Site 24; 🇮🇱 Safed, Israel

Site 32; 🇷🇺 Krasnoyarsk, Russian Federation

Site 25; 🇷🇺 Moscow, Russian Federation

Site 29; 🇷🇺 St. Petersburg, Russian Federation

Site 26; 🇷🇺 Smolensk, Russian Federation

Site 30; 🇷🇺 Voronezh, Russian Federation

Site 9; 🇿🇦 Bloemfontein, South Africa

Site 10; 🇿🇦 Alberton, South Africa

Site 33; 🇿🇦 Hillcrest, South Africa

Site 34; 🇿🇦 Kempton Park, South Africa

Site 11; 🇿🇦 Parow, South Africa

Site 36; 🇿🇦 Umkomaas, South Africa

Site 12; 🇿🇦 Port Elizabeth, South Africa

Site 15; 🇿🇦 Worcester, South Africa

Site 8; 🇿🇦 Pretoria, South Africa

Site 28; 🇷🇺 Novosibirsk, Russian Federation

Site 14; 🇿🇦 Cape Town, South Africa

Site 18; 🇮🇱 Jerusalem, Israel

Site 27; 🇷🇺 Barnaul, Russian Federation

Site 31; 🇷🇺 Kemerovo, Russian Federation

Site 35; 🇿🇦 Durban, South Africa

Site 13; 🇿🇦 Krugersdorp, South Africa

Site 16; 🇿🇦 Komatipoort, South Africa