Back to resultsEfficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
fluvastatin, ezetimibe
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia focused on measuring Dyslipidemia, ezetimibe, inflammatory markers, fluvastatin
Eligibility 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
Sites / Locations
- Novartis
Outcomes
Primary Outcome Measures
Change from baseline in low density lipoprotein cholesterol after 12 weeks
Secondary Outcome 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00171288
Brief Title
Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone
Official Title
Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
Keywords
Dyslipidemia, ezetimibe, inflammatory markers, fluvastatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
fluvastatin, ezetimibe
Primary Outcome Measure Information:
Title
Change from baseline in low density lipoprotein cholesterol after 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in total triglyceride, high density lipoprotein cholesterol, and composition of low density lipoprotein cholesterol after 12 weeks
Title
Change from baseline in circulating marker of inflammation after 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis
City
Madrid
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone
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