Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone
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...
Brief Summary
Official Title: “Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone”
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
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: August 2005
Intervention(s) in this Clinical Trial
- Drug: fluvastatin, ezetimibe
Outcome Measures for this Clinical Trial
Primary Measures
- Change from baseline in low density lipoprotein cholesterol after 12 weeks
Secondary Measures
- 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
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00171288
Study ID Number: CXUO320BES03
ClinicalTrials.gov Identifier: NCT00171288
Health Authority: Spain: Spanish Agency of Medicines
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00171288
