Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone
Phase 3
Completed
- Conditions
- Dyslipidemia
- Registration Number
- NCT00171288
- Lead Sponsor
- Novartis
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in low density lipoprotein cholesterol after 12 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in total triglyceride, high density lipoprotein cholesterol, and composition of low density lipoprotein cholesterol after 12 weeks Change from baseline in circulating marker of inflammation after 12 weeks
Trial Locations
- Locations (1)
Novartis
🇪🇸Madrid, Spain