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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01551173
First received: March 8, 2012
Last updated: March 6, 2014
Last verified: March 2014

March 8, 2012
March 6, 2014
January 2012
May 2013   (final data collection date for primary outcome measure)
Mean percent change in LDL-C from baseline at study endpoint, week 12 (LOCF) [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn at baseline and endpoint.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.
Same as current
Complete list of historical versions of study NCT01551173 on ClinicalTrials.gov Archive Site
  • Mean percent change from baseline in LDL-C at week 4, week 8 and week 12 [ Time Frame: Baseline, week 4, week8, week 12 ] [ Designated as safety issue: No ]
    After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn .An analogous ANCOVA model to that used in the analysis of the primary variable will be used to compare the change from baseline in LDL-C between treatment groups at Week 4, Week 8, Week 12.
  • Mean percent change from baseline at week 4, week 8, week 12, and endpoint for lipid variables (LDL-C, TC, HDL-C, non HDL-C, TG) [ Time Frame: Baseline, week 4, week8, week 12 ] [ Designated as safety issue: No ]
    After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn.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 TC, HDL-C, non HDL-C and TG from baseline between treatment groups at Week 4, Week 8, Week 12 and Endpoint.
  • Proportion of patients achieving their LDL-C treatment goals at week 4, week 8, week 12, and endpoint [ Time Frame: Baseline, week 4, week8, week 12 ] [ Designated as safety issue: No ]
    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.
  • The safety and tolerability of two treatment groups over 12 weeks. [ Time Frame: Week -7, week -6, week -1 ,week 0, week 4, week8, week 12 ] [ Designated as safety issue: Yes ]
    Adverse events, physical exams, Laboratory exams, Vital signs, ECG will be collected to evaluate the safety and tolerability. Descriptive statistics will be used for Continuous parameters; Frequency table will be produced for categorical parameters. Mean change from baseline will be summarized by treatment group and time point for vital signs.
  • The proportion of patients who develop transaminase elevations and/or creatine kinase (CK) elevations during treatment [ Time Frame: Baseline, week 4, week8, week 12 ] [ Designated as safety issue: Yes ]
    Describe the proportion of patients with ALT and/or AST elevations or CK elevations according to different categories (i.e., ≤ 1.15 ULN, > 1.15 to ≤ 2 x ULN; > 2 to ≤ 3 x ULN; > 3 x ULN for ALT and/or AST; ≥ 5 to < 10 x ULN; ≥ 10 x ULN for CK), The percentage of patients meeting the clinically significant or notable elevations criteria will be summarized by treatment. Risk ratios and their corresponding 95% CI will be calculated to compare the treatment groups.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Lipid Metabolism Disorders
Drug: Fluvastatin sodium
Fluvastatin sodium Extended Release Tablets 80mg
  • Experimental: Fluvastatin sodium Extended Release Tablet
    Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
    Interventions:
    • Drug: Fluvastatin sodium
    • Drug: Fluvastatin sodium
  • Active Comparator: Fluvastatin sodium Immediate Release Capsule
    Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
    Interventions:
    • Drug: Fluvastatin sodium
    • Drug: Fluvastatin sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
242
May 2013
May 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01551173
CXUO320BCN01
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP