Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy - Tabular View

Tracking Information

First Received Date ^ICMJE

July 6, 2006

Last Updated Date

July 7, 2009

Start Date ^ICMJE

November 2005

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percent change from baseline to 24 weeks of treatment in Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline to 24 weeks of treatment in HDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline to 24 weeks of treatment in LDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

LDL-C, TG, HDL-C

Change History

Complete list of historical versions of study NCT00349375 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percent change from baseline to 24 weeks of treatment in Triglycerides [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Percent change from baseline to 24 weeks of treatment in HDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Percent change from baseline to 24 weeks of treatment in LDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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. [ Time Frame: 12 and/or 24 weeks ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hyperlipidemia

Intervention ^ICMJE

Drug: Fenofibrate/Simvastatin
Drug: Simvastatin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1040

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Czech Republic, Denmark, France, Germany, Hungary, Netherlands, Poland, Ukraine

Administrative Information

NCT ID ^ICMJE

NCT00349375

Responsible Party

Martine Guy, Solvay Pharmaceuticals

Study ID Numbers ^ICMJE

C LF0242780-01 05 01, 2005-003270-14

Study Sponsor ^ICMJE

Solvay Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

Information Provided By

Solvay Pharmaceuticals

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP