Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00690443
First received: May 20, 2008
Last updated: April 4, 2013
Last verified: April 2013
Results First Received: January 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Hypercholesterolemia
Interventions: Drug: Atorvastatin
Drug: AEGR-733

  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
This study was performed from 12 May 2008 to 29 Aug 2008. A total of 5 medical clinics participated in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
5-week run-in period during which patients were to follow a low-fat diet and washout from previous lipid lowering therapies.

Reporting Groups
  Description
Atorvastatin 20 mg Oral atorvastatin 20 mg for 8 weeks
Atorvastatin 20 mg + Lomitapide Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg

Participant Flow:   Overall Study
    Atorvastatin 20 mg     Atorvastatin 20 mg + Lomitapide  
STARTED     23     21  
COMPLETED     22     19  
NOT COMPLETED     1     2  
Adverse Event                 1                 2  



  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
Atorvastatin 20 mg Oral atorvastatin 20 mg for 8 weeks
Atorvastatin 20 mg + Lomitapide Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
Total Total of all reporting groups

Baseline Measures
    Atorvastatin 20 mg     Atorvastatin 20 mg + Lomitapide     Total  
Number of Participants  
[units: participants]
  23     21     44  
Age  
[units: Years]
Mean ± Standard Deviation
  58.8  ± 6.22     57.8  ± 8.06     58.3  ± 7.09  
Gender  
[units: Participants]
     
Female     13     11     24  
Male     10     10     20  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     18     18     36  
Not Hispanic or Latino     5     3     8  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: Participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     1     1  
White     22     20     42  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: Participants]
     
United States     23     21     44  



  Outcome Measures
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1.  Primary:   Percent Change in LDL-C After 8 Weeks of Therapy   [ Time Frame: Baseline and 8 weeks of treatment ]

2.  Secondary:   Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.   [ Time Frame: Baseline and 4 weeks ]


  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: Chief Medical Officer
Organization: Aegerion Pharmaceuticals
phone: 617-500-7867


No publications provided


Responsible Party: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00690443     History of Changes
Other Study ID Numbers: AEGR 733-006
Study First Received: May 20, 2008
Results First Received: January 18, 2013
Last Updated: April 4, 2013
Health Authority: United States: Food and Drug Administration