Conditions: Lipid Metabolism Disorders
Keywords: Dyslipidemias Fluvastatin sodium Chinese
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 436
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks arm 2: Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks

Interventions: intervention 1: Fluvastatin sodium
Intervention descriptions: intervention 1: Fluvastatin sodium Extended Release Tablets 80mg

Protocol document: