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

Novartis

Status and phase: Completed; Phase 4

Conditions: Lipid Metabolism Disorders

Treatments: Drug: Fluvastatin sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT01551173

CXUO320BCN01

Details and patient eligibility

About

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.

Enrollment: 436 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high CV risk according to Chinese Dyslipidemia Guideline (2007).
• Not having achieved lipid treatment goals despite following a cholesterol restrictive diet and/or lipid lowering monotherapy improperly prior to Visit 1 (inclusion in the 6-week open-label study phase).
• Not having achieved lipid treatment goals on a stable dose of Fluvastatin sodium Immediate Release Capsule 40 mg QD during the 6 week open-label study phase (inclusion in the 12-week double-blind study phase).

Exclusion criteria

• Patients with known hypersensitivity to fluvastatin or any of the excipients.
• Dyslipidemia secondary to other causes.
• Known muscle disease or history of muscle disease and/or serum CPK levels greater than 2 x upper limit of normal (ULN).
• A history or evidence of Acute Myocardial infarction (AMI), unstable angina (UA) or Coronary artery bypass surgery or Percutaneous Coronary Intervention (PCI) within the previous 8 weeks.
• Active liver disease and/or serum transaminase levels (ALT, AST) greater than 1.5 x ULN.
• Patients on a proper lipid lowering monotherapy (defined as at least 12 weeks continuous monotherapy with a recommended dose and administration in the label) within the previous 3 months prior to visit 1.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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436 participants in 2 patient groups

Fluvastatin sodium Extended Release Tablet

Experimental group

Description:

Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks

Treatment:

Drug: Fluvastatin sodium

Fluvastatin sodium Immediate Release Capsule

Active Comparator group

Description:

Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks

Treatment:

Drug: Fluvastatin sodium