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

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ClinicalTrials.gov Identifier: NCT00690443
Recruitment Status : Completed
First Posted : June 4, 2008
Results First Posted : February 25, 2013
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Hypercholesterolemia
Interventions Drug: Atorvastatin
Drug: AEGR-733
Enrollment 44
Recruitment Details 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 5-week run-in period during which patients were to follow a low-fat diet and washout from previous lipid lowering therapies.
Arm/Group Title Atorvastatin 20 mg Atorvastatin 20 mg + Lomitapide
Hide Arm/Group Description Oral atorvastatin 20 mg for 8 weeks Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
Period Title: Overall Study
Started 23 21
Completed 22 19
Not Completed 1 2
Reason Not Completed
Adverse Event             1             2
Arm/Group Title Atorvastatin 20 mg Atorvastatin 20 mg + Lomitapide Total
Hide Arm/Group Description Oral atorvastatin 20 mg for 8 weeks 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 of all reporting groups
Overall Number of Baseline Participants 23 21 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 21 participants 44 participants
58.8  (6.22) 57.8  (8.06) 58.3  (7.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 44 participants
Female
13
  56.5%
11
  52.4%
24
  54.5%
Male
10
  43.5%
10
  47.6%
20
  45.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 44 participants
Hispanic or Latino
18
  78.3%
18
  85.7%
36
  81.8%
Not Hispanic or Latino
5
  21.7%
3
  14.3%
8
  18.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 44 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   4.3%
0
   0.0%
1
   2.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   4.8%
1
   2.3%
White
22
  95.7%
20
  95.2%
42
  95.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 21 participants 44 participants
23 21 44
1.Primary Outcome
Title Percent Change in LDL-C After 8 Weeks of Therapy
Hide Description [Not Specified]
Time Frame Baseline and 8 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atorvastatin 20 mg Atorvastatin 20 mg + Lomitapide
Hide Arm/Group Description:
Oral atorvastatin 20 mg for 8 weeks
Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
Overall Number of Participants Analyzed 22 19
Mean (Standard Deviation)
Unit of Measure: Percent Change
-39.6  (14.35) -49.9  (26.78)
2.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atorvastatin 20 mg Atorvastatin 20 mg + Lomitapide
Hide Arm/Group Description:
Oral atorvastatin 20 mg for 8 weeks
Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
Overall Number of Participants Analyzed 23 19
Mean (Standard Deviation)
Unit of Measure: Percent
Change in LDL-C -42.5  (12.70) -51.0  (18.34)
Change in TC -31.3  (9.23) -38.1  (15.38)
Change in TGs -21.5  (18.31) -17.8  (28.32)
Change in HDL-C 6.7  (8.07) -1.9  (10.73)
Change in non-HDL-C -39.6  (10.78) -45.8  (17.68)
Change in Apo B -33.6  (10.19) -37.7  (17.05)
Change in Apo A-1 4.8  (7.53) -7.8  (8.85)
Change in hs-CRP -12.0  (43.21) 60.5  (187.50)
Change in body weight 0.0  (1.38) -0.7  (1.49)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atorvastatin 20 mg Atorvastatin 20 mg + Lomitapide
Hide Arm/Group Description Oral atorvastatin 20 mg for 8 weeks Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
All-Cause Mortality
Atorvastatin 20 mg Atorvastatin 20 mg + Lomitapide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Atorvastatin 20 mg Atorvastatin 20 mg + Lomitapide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      0/21 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atorvastatin 20 mg Atorvastatin 20 mg + Lomitapide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/23 (69.57%)      16/21 (76.19%)    
Gastrointestinal disorders     
Diarrhoea *  3/23 (13.04%)  3 10/21 (47.62%)  10
Flatuence *  2/23 (8.70%)  2 4/21 (19.05%)  4
Nausea *  2/23 (8.70%)  2 3/21 (14.29%)  3
Abdominal distension *  3/23 (13.04%)  3 1/21 (4.76%)  1
Dyspepsia *  0/23 (0.00%)  0 3/21 (14.29%)  3
Constipation *  2/23 (8.70%)  2 1/21 (4.76%)  1
Infections and infestations     
Urinary tract infection *  0/23 (0.00%)  0 3/21 (14.29%)  3
Injury, poisoning and procedural complications     
Foot fracture *  2/23 (8.70%)  2 0/21 (0.00%)  0
Investigations     
Alanine aminotransferase increased *  0/23 (0.00%)  0 4/21 (19.05%)  4
Nervous system disorders     
Headache *  2/23 (8.70%)  2 3/21 (14.29%)  3
Skin and subcutaneous tissue disorders     
Dermal cyst *  0/23 (0.00%)  0 2/21 (9.52%)  2
*
Indicates events were collected by non-systematic assessment
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.
Information is unavailable.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Aegerion Pharmaceuticals
Phone: 617-500-7867
Layout table for additonal information
Responsible Party: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00690443    
Other Study ID Numbers: AEGR-733-006
First Submitted: May 20, 2008
First Posted: June 4, 2008
Results First Submitted: January 18, 2013
Results First Posted: February 25, 2013
Last Update Posted: February 23, 2018