NCT01551173

Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

A 12-week, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group Study to Assess the Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily Compared to Fluvastatin Sodium Immediate Release Capsules 40 mg Twice Daily (BID) in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia at Moderate or High Cardiovascular Risk Who Did Not Achieve Their Lipid Goals When Treated With Fluvastatin Sodium Immediate Release Capsules 40 mg QD

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 436 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to demonstrate therapeutic comparability of Fluvastatin sodium Extended Release Tablets 80 mg QD and Fluvastatin sodium Immediate Release Capsules 40 mg BID in LDL-C lowering from baseline to week 12 (endpoint) in patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high CV risk who did not achieve their lipid goals when treated with Fluvastatin sodium Immediate Release Capsules 40 mg QD.

Conditions

• Lipid Metabolism Disorders

Interventions

Type	Name	Description
DRUG	Fluvastatin sodium	Fluvastatin sodium Extended Release Tablets 80mg

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-03-12
• Last updated: 2015-08-13
• Results posted: 2014-06-11

Locations

1 site across 1 country: China