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AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00474240
First received: May 14, 2007
Last updated: January 15, 2014
Last verified: January 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 20 mg
Drug: AEGR-733 5 mg
Drug: AEGR-733 10 mg
Drug: Placebo
Drug: AEGR-733 5 mg + atorvastatin 20 mg
Drug: AEGR-733 10 mg + atorvastatin 20 mg

  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
The study was performed from 05 November 2007 to 04 August 2008 at 17 medical clinics within the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who were previously on a lipid lowering therapy underwent a 5-week washout period. All subjects were on a low-fat diet (<30% calories from fat) starting 5 weeks prior to study drug treatment and continuing for the duration of the study.

Reporting Groups
  Description
Placebo Placebo capsule taken orally once daily
Atorvastatin 20 mg Atorvastatin 20 mg taken orally once daily
AEGR-733 5 mg AEGR-733 5 mg taken orally once daily
AEGR-733 10 mg AEGR-733 10 mg taken orally once daily
AEGR-733 5 mg + Atorvastatin 20 mg One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
AEGR-733 10 mg + Atorvastatin 20 mg One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily

Participant Flow:   Overall Study
    Placebo     Atorvastatin 20 mg     AEGR-733 5 mg     AEGR-733 10 mg     AEGR-733 5 mg + Atorvastatin 20 mg     AEGR-733 10 mg + Atorvastatin 20 mg  
STARTED     27     26     26     26     26     26  
COMPLETED     26     25     17     10     18     8  
NOT COMPLETED     1     1     9     16     8     18  
Withdrawal by Subject                 1                 1                 0                 2                 3                 1  
Adverse Event                 0                 0                 9                 14                 5                 16  
Removed due to lab value                 0                 0                 0                 0                 0                 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
Placebo Placebo capsule taken orally once daily
Atorvastatin 20 mg Atorvastatin 20 mg taken orally once daily
AEGR-733 5 mg AEGR-733 5 mg taken orally once daily
AEGR-733 10 mg AEGR-733 10 mg taken orally once daily
AEGR-733 5 mg + Atorvastatin 20 mg One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
AEGR-733 10 mg + Atorvastatin 20 mg One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
Total Total of all reporting groups

Baseline Measures
    Placebo     Atorvastatin 20 mg     AEGR-733 5 mg     AEGR-733 10 mg     AEGR-733 5 mg + Atorvastatin 20 mg     AEGR-733 10 mg + Atorvastatin 20 mg     Total  
Number of Participants  
[units: participants]
  27     26     26     26     26     26     157  
Age  
[units: Years]
Mean ± Standard Deviation
  53  ± 11.1     56  ± 8.4     56  ± 8.3     54  ± 11.6     51  ± 10.1     53  ± 9.7     54  ± 10  
Gender  
[units: participants]
             
Female     13     16     16     16     10     16     87  
Male     14     10     10     10     16     10     70  
Ethnicity (NIH/OMB)  
[units: Participants]
             
Hispanic or Latino     0     0     1     3     3     0     7  
Not Hispanic or Latino     27     26     25     23     23     26     150  
Unknown or Not Reported     0     0     0     0     0     0     0  
Race (NIH/OMB)  
[units: Participants]
             
American Indian or Alaska Native     0     0     0     0     0     1     1  
Asian     1     0     0     0     0     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0     0     0  
Black or African American     4     5     2     4     5     3     23  
White     22     21     23     21     18     22     127  
More than one race     0     0     0     0     0     0     0  
Unknown or Not Reported     0     0     1     1     3     0     5  
Region of Enrollment  
[units: participants]
             
United States     27     26     26     26     26     26     157  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change From Baseline in LDL-C at 8 Weeks   [ Time Frame: Atfer 8 weeks on study drug ]

2.  Secondary:   Percent Change From Baseline of Other Lipids   [ Time Frame: After 8 weeks of study drug ]


  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
Study AEGR-733-003, initiated in May 2007, was halted, and restarted under an amended Protocol in November 2007.


  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


Publications:

Responsible Party: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00474240     History of Changes
Other Study ID Numbers: 733-003
Study First Received: May 14, 2007
Results First Received: January 18, 2013
Last Updated: January 15, 2014
Health Authority: United States: Food and Drug Administration