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

This study has been completed.
Sponsor:
Information provided by:
Radiant Research
ClinicalTrials.gov Identifier:
NCT00673881
First received: May 5, 2008
Last updated: March 25, 2011
Last verified: March 2011
Results First Received: January 24, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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.
No text entered.

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

Baseline Measures
    ABT 335  
Number of Participants  
[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  
Triglycerides (TG) [2]
[units: mg/dL]
Mean ± Standard Deviation
  241  ± 122  
High Density Lipoprotein Cholesterol (HDL) [3]
[units: mg/dL]
Mean ± Standard Deviation
  34  ± 8.2  
Low density lipoprotein cholesterol (LDL) [4]
[units: mg/dL]
Mean ± Standard Deviation
  144  ± 40  
[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
[2] 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
[3] 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
[4] 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
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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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

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

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

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

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

10.  Secondary:   Neutral Sterol Endogenous Excretion   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Endogenous Bile Acid Excretion   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


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


No publications provided


Responsible Party: Michael H. Davidson,MD, FACC, Radiant Research
ClinicalTrials.gov Identifier: NCT00673881     History of Changes
Other Study ID Numbers: ABT-335-001
Study First Received: May 5, 2008
Results First Received: January 24, 2011
Last Updated: March 25, 2011
Health Authority: United States: Food and Drug Administration