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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00362934 |
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Date of registration:
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11/08/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin
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Scientific title:
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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 |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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516 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00362934 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Bulgaria
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Czech Republic
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Germany
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Slovakia
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Ukraine
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Contacts
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Name:
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Global Clinical Director Solvay |
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Address:
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Telephone:
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Email:
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Affiliation:
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Solvay Pharmaceuticals |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hyperlipidemia
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Intervention(s)
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Drug: fenofibrate / simvastatin
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Drug: Atorvastatin
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Primary Outcome(s)
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Percent change from baseline to 12 weeks of treatment in HDL-C
[Time Frame: 12 weeks]
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Percent change from baseline to 12 weeks of treatment in LDL-C
[Time Frame: 12 weeks]
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Percent change from baseline to 12 weeks of treatment in Triglycerides
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Percent change from baseline to 12 weeks of treatment in LDL-C
[Time Frame: 24 weeks]
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Percent change from baseline to 12 weeks of treatment in HDL-C
[Time Frame: 24 weeks]
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Percent change from baseline to 12 weeks of treatment in Triglycerides
[Time Frame: 24 weeks]
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Secondary ID(s)
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2006-000519-21
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C LF0242780-01 05 03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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