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ABT-335 (Choline Fenofibrate) Reverse Cholesterol Transport (RCT) Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00673881
First Posted: May 7, 2008
Last Update Posted: April 20, 2011
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:
Radiant Research
Results First Submitted: January 24, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Dyslipidemia
Intervention: Drug: choline 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
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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
ABT 335 choline fenofibrate, 135 mg/day,orally, 12 weeks

Participant Flow:   Overall Study
    ABT 335
STARTED   25 
COMPLETED   24 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  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.
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Reporting Groups
  Description
ABT 335 choline fenofibrate, 135 mg/day,orally, 12 weeks

Baseline Measures
   ABT 335 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   23 
>=65 years   2 
Gender 
[Units: Participants]
 
Female   7 
Male   18 
Region of Enrollment 
[Units: Participants]
 
United States   25 
Total cholesterol (TC) [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 221  (45) 
[1] Mean of fasting (> 12 hours) total cholesterol measured at screening, Day 0, 1PM and Day 1, 1AM (Visit 1),Day 10 (Visit 4);23 values, per protocol population
Triglycerides (TG) [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 241  (122) 
[1] Mean fasting (> 12 hours) triglycerides measured at screening, Day 0, 1PM and Day 1, 1AM (Visit 1), Day 10 (Visit 4);23 values, per protocol population
High Density Lipoprotein Cholesterol (HDL) [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 34  (8.2) 
[1] Mean fasting (> 12 hours) HDL cholesterol measured at screening, Day 0, 1PM and Day 1, 1AM (Visit 1), Day 10 (Visit 4); 23 values, per protocol population
Low density lipoprotein cholesterol (LDL) [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 144  (40) 
[1] Mean fasting (> 12 hours) LDL cholesterol measured at screening, Day 0, 1PM and Day 1, 1AM (Visit 1), Day 10 (Visit 4); 23 values, per protocol population


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change in Calculated Low Density Lipoprotein Cholesterol   [ Time Frame: baseline to 12 weeks ]

2.  Primary:   Mean Change in Plasma Triglycerides   [ Time Frame: baseline to 12 weeks ]

3.  Primary:   Mean Change in High Density Lipoprotein Cholesterol   [ Time Frame: Baseline to 12 weeks ]

4.  Primary:   Total Cholesterol   [ Time Frame: 12 weeks ]

5.  Secondary:   Plasma Cholesterol Efflux   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Change in Plasma Cholesterol Ester Fractional Catabolic Rate (FCR)   [ Time Frame: Baseline to 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Percent Change in de Novo Cholesterol Synthesis   [ Time Frame: Baseline to 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Change in Neutral Sterol Excretion   [ Time Frame: baseline to 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Change in Bile Acid Excretion   [ Time Frame: Baseline to 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Secondary:   Neutral Sterol Endogenous Excretion   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Secondary:   Endogenous Bile Acid Excretion   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Michael H. Davidson, MD FACC
Organization: Radiant Research
phone: 312-494-2220 ext 2220
e-mail: michaeldavidson@radiantresearch.com



Responsible Party: Michael H. Davidson,MD, FACC, Radiant Research
ClinicalTrials.gov Identifier: NCT00673881     History of Changes
Other Study ID Numbers: ABT-335-001
First Submitted: May 5, 2008
First Posted: May 7, 2008
Results First Submitted: January 24, 2011
Results First Posted: April 20, 2011
Last Update Posted: April 20, 2011