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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

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: November 4, 2014
Last verified: November 2014
Results First Received: May 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Lipid Metabolism Disorders
Intervention: Drug: Fluvastatin sodium

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Fluvastatin Sodium Extended Release Tablet Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
Fluvastatin Sodium Immediate Release Capsule Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks

Participant Flow:   Overall Study
    Fluvastatin Sodium Extended Release Tablet     Fluvastatin Sodium Immediate Release Capsule  
STARTED     218 [1]   218  
Full Analysis Set (FAS)     210 [2]   214  
COMPLETED     190     186  
NOT COMPLETED     28     32  
Withdrawal by Subject                 11                 16  
Adverse Event                 7                 6  
Lost to Follow-up                 5                 7  
Not specified                 5                 3  
[1] "Started" indicates randomized
[2] Patients took at least 1 dose of study drug & had at least 1 post-randomization efficacy parameter



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized Set (RAN)

Reporting Groups
  Description
Fluvastatin Sodium Extended Release Tablet Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
Fluvastatin Sodium Immediate Release Capsule Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Fluvastatin Sodium Extended Release Tablet     Fluvastatin Sodium Immediate Release Capsule     Total  
Number of Participants  
[units: participants]
  218     218     436  
Age  
[units: Years]
Mean ± Standard Deviation
  58.8  ± 8.39     60.4  ± 9.30     59.6  ± 8.88  
Gender  
[units: Participants]
     
Female     142     154     296  
Male     76     64     140  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Percent Change in LDL-C From Baseline at Study Endpoint, Week 12 (LOCF)   [ Time Frame: Baseline, week 12 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300
e-mail: trialandresults.registries@novartis.com


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01551173     History of Changes
Other Study ID Numbers: CXUO320BCN01
Study First Received: March 8, 2012
Results First Received: May 13, 2014
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration
China: The State Food and Drug Administration (SFDA)