A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic

This study has been completed.
Sponsor:
Collaborator:
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01462877
First received: October 28, 2011
Last updated: February 25, 2015
Last verified: February 2015
Results First Received: February 6, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Dyslipidemias
Cardiovascular Diseases
Hypertriglyceridemia
Intervention: Drug: fenofibrate

  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
Dyslipidemic Chinese patients with CHD or CHD equivalent, whose TG ≥1.70 mmol/L and <5.65mmol/L after at least 2 month statin monotherapy with standard dose were enrolled. After at least 2 month statin monotherapy with standard dose, patients having high TG were recruited and given statin-fenofibrate combination therapy for 8 weeks.

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
Fenofibrate Arm fenofibrate: Fenofibrate Capsule 200mg qd orally

Participant Flow:   Overall Study
    Fenofibrate Arm  
STARTED     506  
Safety Set     492  
Full Analysis Set     468  
Per-protocol Set     364  
COMPLETED     435  
NOT COMPLETED     71  



  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.
Full Analysis Set

Reporting Groups
  Description
Fenofibrate Arm fenofibrate: Fenofibrate Capsule 200mg qd orally

Baseline Measures
    Fenofibrate Arm  
Number of Participants  
[units: participants]
  468  
Age  
[units: years]
Mean ± Standard Deviation
  58  ± 9.91  
Gender  
[units: participants]
 
Female     194  
Male     274  
Systolic blood pressure  
[units: mmHg]
Mean ± Standard Deviation
  130.93  ± 12.50  
diastolic blood pressure  
[units: mmHg]
Mean ± Standard Deviation
  78.54  ± 8.97  



  Outcome Measures
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1.  Primary:   Percentage of Triglyceride (TG) Change   [ Time Frame: Baseline and up to 8 weeks after intervention ]

2.  Secondary:   Change in Serum Total Cholesterol   [ Time Frame: Baseline and up to 8 weeks after intervention ]

3.  Secondary:   Change in Serum Low-density Lipoprotein Cholesterol   [ Time Frame: Baseline up to 8 weeks after intervention ]

4.  Secondary:   Change in Serum High-density Lipoprotein Cholesterol   [ Time Frame: Baseline up to 8 weeks after intervention ]

5.  Secondary:   Change in Serum Non-high-density Lipoprotein Cholesterol   [ Time Frame: Baseline up to 8 weeks after intervention ]

6.  Secondary:   Change in Serum Apolipoprotein A1   [ Time Frame: Baseline up to 8 weeks after intervention ]

7.  Secondary:   Change in Serum Apolipoprotein B   [ Time Frame: Baseline up to 8 weeks after intervention ]

8.  Secondary:   Change in Serum Alanine Aminotransferase   [ Time Frame: Baseline up to 8 weeks after intervention ]

9.  Secondary:   Change in Serum Aspartate Aminotransferase   [ Time Frame: Baseline up to 8 weeks after intervention ]

10.  Secondary:   Change in Serum Creatine Kinase   [ Time Frame: Baseline up to 8 weeks after intervention ]

11.  Secondary:   Change in Serum Creatinine   [ Time Frame: Baseline up to 8 weeks after intervention ]

12.  Secondary:   Change in Serum High Sensitivity C-reactive Protein   [ Time Frame: Baseline and up to 8 weeks after intervention ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: Associate Director Clinical Services
Organization: Abbott
e-mail: taco.baardman@abbott.com


No publications provided


Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01462877     History of Changes
Other Study ID Numbers: W13-254
Study First Received: October 28, 2011
Results First Received: February 6, 2015
Last Updated: February 25, 2015
Health Authority: China: Food and Drug Administration