drugset / Trial / NCT01551173

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

NCT01551173

Phase 4 Completed 436 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2012-01
Primary completion
2013-05
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluvastatin Other / unclassified 40 mg Oral
Subject Fluvastatin Other / unclassified 80 mg Oral