Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia

Phase 3

Completed

• Conditions: Mixed Dyslipidemia; Hypercholesterolemia

• Registration Number: NCT00136799
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-29
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

• Mixed dyslipidemia
• Primary hypercholesterolemia

Exclusion Criteria

• Pregnant or lactating women
• Age > 18 years

Other protocol-defined inclusion and exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis; 🇨🇳 Shangai, China