Back to resultsEfficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia
Primary Purpose
Mixed Dyslipidemia, Hypercholesterolemia
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Fluvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Mixed Dyslipidemia focused on measuring Mixed Dyslipidemia, high cholesterol, adults, fluvastatin
Eligibility Criteria
Inclusion Criteria: Mixed dyslipidemia Primary hypercholesterolemia Exclusion Criteria: Pregnant or lactating women Age > 18 years Other protocol-defined inclusion and exclusion criteria may apply.
Sites / Locations
- Novartis
Outcomes
Primary Outcome Measures
Percent change from baseline in low density lipoprotein cholesterol after 12 weeks
Secondary Outcome Measures
Percent change from baseline in total cholesterol after 12 weeks
Percent change from baseline in high density lipoprotein cholesterol after 12 weeks
Percent change from baseline in total triglycerides after 12 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00136799
Brief Title
Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia
Official Title
Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to evaluate the safety and tolerability of fluvastatin 80 mg in a Chinese population. This study is not recruiting patients in the US.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mixed Dyslipidemia, Hypercholesterolemia
Keywords
Mixed Dyslipidemia, high cholesterol, adults, fluvastatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
325 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fluvastatin
Primary Outcome Measure Information:
Title
Percent change from baseline in low density lipoprotein cholesterol after 12 weeks
Secondary Outcome Measure Information:
Title
Percent change from baseline in total cholesterol after 12 weeks
Title
Percent change from baseline in high density lipoprotein cholesterol after 12 weeks
Title
Percent change from baseline in total triglycerides after 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mixed dyslipidemia
Primary hypercholesterolemia
Exclusion Criteria:
Pregnant or lactating women
Age > 18 years
Other protocol-defined inclusion and exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis
City
Shangai
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia
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