Clinical trial NCT01551173: Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lipid Metabolism Disorders
Keywords: Dyslipidemias
Fluvastatin sodium
Chinese
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-03-12
Enrollment: 436
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Percent Change in LDL-C From Baseline at Study Endpoint, Week 12 (LOCF)
timeFrame: Baseline, week 12
Secondary outcomes:
measure: Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG)
timeFrame: Baseline, week 4, week 8, week 12, Endpoint
measure: Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint
timeFrame: Baseline, week 4, week 8, week 12, Endpoint
Other outcomes:
Locations:
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: