At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 436 enrolled
Drug / intervention
Fluvastatin sodiumdrug
Likely dose
Fluvastatin sodium 80mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Fluvastatin sodium for Lipid Metabolism Disorders. Completed, enrolled 436 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLipid Metabolism Disorders
CountriesChina
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2012
First PostedMar 2012
Primary CompletionMay 2013
TodayJul 2026
First PostedMar 12, 2012
Enrollment StartJan 1, 2012
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.3 years ago
Interventions
Fluvastatin sodiumdrug
Fluvastatin sodium Extended Release Tablets 80mg