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

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

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 Overview

• Status: Completed
• Conditions: Lipid Metabolism Disorders
• Intervention / Treatment: Drug: Fluvastatin sodium

• Study Type: Interventional
• Enrollment (Actual): 436
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluvastatin sodium Extended Release Tablet; Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks	Drug: Fluvastatin sodium; Fluvastatin sodium Extended Release Tablets 80mg
Active Comparator: Fluvastatin sodium Immediate Release Capsule; Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks	Drug: Fluvastatin sodium; Fluvastatin sodium Extended Release Tablets 80mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change in LDL-C From Baseline at Study Endpoint, Week 12 (LOCF)	After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn at baseline and endpoint. An analysis of covariance (ANCOVA) with treatment, center, and indication category as factors and baseline LDL-C as a covariate will be used to analyze percent change from baseline in LDL-C.	Baseline, week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn. An analogous ANCOVA model to that used in the analysis of the primary variable will be used to compare the change in LDL-C, TC, HDL-C, non HDL-C and TG from baseline between treatment groups at Week 4, Week 8, and Week 12	Baseline, week 4, week 8, week 12, Endpoint
Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint	LDL-C treatment goal is defined as patients at moderate CV risk with LDL-C levels < 3.37 mmol/L (130 mg/dL) or patients at high CV-risk with LDL-C levels < 2.59 mmol/L (100 mg/dL). The proportion of patients in each treatment group achieving their LDL-C goal during the double-blind period will be compared at Week 4, Week 8, Week 12 and Endpoint using a logistic regression model with treatment and center as factors and baseline LDL-C as a covariate. Odds ratio estimates derived from the logistic regression model and 95%CI will be used to quantify the treatment effect.	Baseline, week 4, week 8, week 12, Endpoint

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: March 8, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (Estimate): March 12, 2012

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 10, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Chinese; Dyslipidemias; Fluvastatin sodium
• Additional Relevant MeSH Terms: Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: CXUO320BCN01