Official Title: “Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Fluvastatin

Primary Measures

• Percent change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary 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

Inclusion Criteria:

• Mixed dyslipidemia
• Primary hypercholesterolemia

Exclusion Criteria:

• Pregnant or lactating women
• Age > 18 years
• Other protocol-defined inclusion 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: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Director Novartis  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00136799

Study ID Number: CXUO320B2302

ClinicalTrials.gov Identifier: NCT00136799

Health Authority: China: State Food and Drug Administration