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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluvastatin | Other / unclassified | 40 mg | Oral |
| Subject | Fluvastatin | Other / unclassified | 80 mg | Oral |