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

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ClinicalTrials.gov Identifier: NCT01551173
Recruitment Status : Completed
First Posted : March 12, 2012
Results First Posted : June 11, 2014
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE March 8, 2012
First Posted Date  ICMJE March 12, 2012
Results First Submitted Date  ICMJE May 13, 2014
Results First Posted Date  ICMJE June 11, 2014
Last Update Posted Date August 13, 2015
Study Start Date  ICMJE January 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2012)
Mean Percent Change in LDL-C From Baseline at Study Endpoint, Week 12 (LOCF) [ Time Frame: Baseline, week 12 ]
After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn at baseline and endpoint.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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01551173 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
  • 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) [ Time Frame: Baseline, week 4, week 8, week 12, Endpoint ]
    After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn.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
  • Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint [ Time Frame: Baseline, week 4, week 8, week 12, 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2012)
  • Mean percent change from baseline in LDL-C at week 4, week 8 and week 12 [ Time Frame: Baseline, week 4, week8, week 12 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Lipid Metabolism Disorders
Intervention  ICMJE Drug: Fluvastatin sodium
Fluvastatin sodium Extended Release Tablets 80mg
Study Arms  ICMJE
  • Experimental: Fluvastatin sodium Extended Release Tablet
    Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
    Intervention: Drug: Fluvastatin sodium
  • Active Comparator: Fluvastatin sodium Immediate Release Capsule
    Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
    Intervention: Drug: Fluvastatin sodium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2014)
436
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2012)
440
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01551173
Other Study ID Numbers  ICMJE CXUO320BCN01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date August 2015

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