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Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00639158
First received: March 14, 2008
Last updated: June 9, 2011
Last verified: June 2011
Results First Received: October 2, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Dyslipidemias
Coronary Heart Disease
Combined (Atherogenic) Dyslipidemia
Mixed Dyslipidemia
Interventions: Drug: ABT-335
Drug: placebo
Drug: atorvastatin
Drug: ezetimibe

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One subject was randomized to the atorvastatin and ezetimibe treatment group and never received study drug.

Reporting Groups
  Description
ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe No text entered.
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe No text entered.

Participant Flow:   Overall Study
    ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe     Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe  
STARTED     272 [1]   270 [2]
COMPLETED     246 [3]   240 [4]
NOT COMPLETED     26     30  
[1] All randomized subjects were treated.
[2] 1 subject was randomized but not treated because of an abnormal ECG that precluded treatment.
[3] 26 subjects prematurely discontinued treatment.
[4] 30 subjects prematurely discontinued treatment



  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 + 40 mg Atorvastatin + 10 mg Ezetimibe No text entered.
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe No text entered.
Total Total of all reporting groups

Baseline Measures
    ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe     Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe     Total  
Number of Participants  
[units: participants]
  272     270     542  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     227     206     433  
>=65 years     45     64     109  
Age  
[units: years]
Mean ± Standard Deviation
  54.4  ± 11.23     56.4  ± 10.67     55.4  ± 10.99  
Age  
[units: participants]
Mean ± Standard Deviation
     
United States     54.4  ± 11.23     56.4  ± 10.67     55.4  ± 10.99  
Gender  
[units: participants]
     
Female     143     155     298  
Male     129     115     244  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Median Percent Change in Triglycerides From Baseline to Final Visit   [ Time Frame: Baseline to 12 Weeks (Final Visit) ]

2.  Primary:   Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit   [ Time Frame: Baseline to 12 weeks (Final Visit) ]

3.  Secondary:   Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit   [ Time Frame: Baseline to 12 weeks (Final Visit) ]

4.  Secondary:   Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit   [ Time Frame: Baseline to 12 weeks (final visit) ]

5.  Secondary:   Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit   [ Time Frame: Baseline to 12 weeks (Final Visit) ]

6.  Secondary:   Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit   [ Time Frame: Baseline to 12 weeks (Final Visit) ]

7.  Secondary:   Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit   [ Time Frame: Baseline to 12 weeks (Final Visit) ]

8.  Secondary:   Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit   [ Time Frame: Baseline to 12 weeks (Final Visit) ]


  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
No text entered.


  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: Global Medical Services
Organization: Abbott
phone: 800-633-9110


No publications provided by Abbott

Publications automatically indexed to this study:

Responsible Party: Maureen Kelly, MD, Abbott
ClinicalTrials.gov Identifier: NCT00639158     History of Changes
Other Study ID Numbers: M10-275
Study First Received: March 14, 2008
Results First Received: October 2, 2009
Last Updated: June 9, 2011
Health Authority: United States: Food and Drug Administration