Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin

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 40 mg Pravastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 40 mg Pravastatin Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362206
• Other study ID #: C LF0242780-01 05 04
• Secondary ID: 2006-000515-15
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2006
• Last updated: July 7, 2009
• Start date: September 2006
• Est. completion date: September 2008

Study information

• Verified date: July 2009
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of MedicinesIsrael: Ministry of HealthRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationSouth Africa: Medicines Control Council
• 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 pravastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 423
• 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 fenofibrates or simvastatin or pravastatin

• Pregnant or lactating women

• Contra-indication to fenofibrate or simvastatin or pravastatin

• 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 20mg
• Fenofibrate/Simvastatin
Combination of Fenofibrate and Simvastatin 40 mg
• Pravastatin
Pravastatin 40 mg

Locations

Country	Name	City	State
Greece	Site 40	Athens
Greece	Site 39	Ioannina
Greece	Site 41	Thessaloniki
Israel	Site 37	Beer Yaakov
Israel	Site 19	Haifa
Israel	Site 22	Holon
Israel	Site 18	Jerusalem
Israel	Site 38	Kfar Saba
Israel	Site 17	Ramat Gan
Israel	Site 21	Ramat Gan
Israel	Site 20	Rechovot
Israel	Site 24	Safed
Israel	Site 23	Tel-Aviv
Romania	Site 5	Arad
Romania	Site 7	Bacau
Romania	Site 1	Bucuresti
Romania	Site 6	Cluj-Napoca
Romania	Site 4	Oradea
Romania	Site 3	Ploiesti
Romania	Site 2	Targu Mures
Russian Federation	Site 27	Barnaul
Russian Federation	Site 31	Kemerovo
Russian Federation	Site 32	Krasnoyarsk
Russian Federation	Site 25	Moscow
Russian Federation	Site 28	Novosibirsk
Russian Federation	Site 26	Smolensk
Russian Federation	Site 29	St. Petersburg
Russian Federation	Site 30	Voronezh
South Africa	Site 10	Alberton
South Africa	Site 9	Bloemfontein
South Africa	Site 14	Cape Town
South Africa	Site 35	Durban
South Africa	Site 33	Hillcrest
South Africa	Site 34	Kempton Park
South Africa	Site 16	Komatipoort
South Africa	Site 13	Krugersdorp
South Africa	Site 11	Parow
South Africa	Site 12	Port Elizabeth
South Africa	Site 8	Pretoria
South Africa	Site 36	Umkomaas
South Africa	Site 15	Worcester

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

Greece,  Israel,  Romania,  Russian Federation,  South Africa, 

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