Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyslipidemia
Intervention: fluvastatin, ezetimibe (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis
Summary
The objective of this study is to assess the effect of the combination treatment on
C-reactive protein and inflammatory markers as well as the safety and tolerability in a
Spanish population
Clinical Details
Official title: Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in low density lipoprotein cholesterol after 12 weeks
Secondary outcome: Change from baseline in total triglyceride, high density lipoprotein cholesterol, and composition of low density lipoprotein cholesterol after 12 weeksChange from baseline in circulating marker of inflammation after 12 weeks
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients aged 18-75 Primary hypercholesterolemia Signed informed consent
Exclusion Criteria:
- Patients involved in clinical trials 3 months prior to inclusion Patients treated with
drugs specified in protocol Fertile women not using contraceptive methods
Other protocol defined in and exclusion criteria may apply
Locations and Contacts
Novartis, Madrid, Spain
Additional Information
Starting date: August 2003
Last updated: March 20, 2008
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