We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01551173
First Posted: March 12, 2012
Last Update Posted: August 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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.

Condition Intervention Phase
Lipid Metabolism Disorders Drug: Fluvastatin sodium Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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    After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn at baseline and endpoint.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.


Secondary Outcome Measures:
  • 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.


Enrollment: 436
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01551173


Locations
China, Hunan
Novartis Investigative Site
Changsha, Hunan, China, 410011
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01551173     History of Changes
Other Study ID Numbers: CXUO320BCN01
First Submitted: March 8, 2012
First Posted: March 12, 2012
Results First Submitted: May 13, 2014
Results First Posted: June 11, 2014
Last Update Posted: August 13, 2015
Last Verified: August 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Dyslipidemias
Fluvastatin sodium
Chinese

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Metabolic Diseases
Lipid Metabolism Disorders
Hyperlipidemias
Fluvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors


To Top