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...
Date First Received: September 12, 2005
Last Updated: March 20, 2008
Verified by: Novartis, March 2008
Clinical Trial Phase: Phase 3 | Start Date: August 2003
Overall Status: Completed
Estimated Enrollment: 80
Brief Summary
Official Title: “Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone”
Condition Keyword(s):
Intervention(s):
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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 Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on December 03, 2008
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
Clinical Trials Authorship and Review
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