A Controlled-Study of Fenofibrate 145 mg and Ezetimibe 10 mg in Type IIb Dyslipidemic Patients With Features of the Metabolic Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00349284
• Date of registration: 05/07/2006
• Prospective Registration: No
• Primary sponsor: Solvay Pharmaceuticals
• Public title: A Controlled-Study of Fenofibrate 145 mg and Ezetimibe 10 mg in Type IIb Dyslipidemic Patients With Features of the Metabolic Syndrome
• Scientific title: A Randomised, Double-Blind Study Comparing the Efficacy and Safety of 145 mg Fenofibrate, 10 mg Ezetimibe and Their Combination in Patients With Type IIb Dyslipidemia and Features of the Metabolic Syndrome
• Date of first enrolment: January 2005
• Target sample size: 181
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00349284
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Belgium, France, Germany

Contacts

• Name: Global Clinical Director Solvay
• Affiliation: Solvay Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Type IIb dyslipidemia.

Exclusion Criteria:

- Known hypersensitivity to fibrates or ezetimibe. Pregnant or lactating women.
Contra-indication to fenofibrate or ezetimibe.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hyperlipidemia Combined

Intervention(s)

Drug: Combination of 145 mg fenofibrate and 10 mg ezetimibe

Primary Outcome(s)

TG and HDL-C levels.

Secondary ID(s)

2004-002408-13

C LF 178P 04 01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors