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Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS

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ClinicalTrials.gov Identifier: NCT00559962
Recruitment Status : Completed
First Posted : November 19, 2007
Results First Posted : February 22, 2013
Last Update Posted : February 23, 2018
Sponsor:
Information provided by:
Aegerion Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Hyperlipidemia
Interventions Drug: AEGR-733
Drug: placebo
Drug: AEGR-733 and atorvastatin
Drug: AEGR-733 and fenofibrate
Drug: AEGR-733 and ezetimibe
Enrollment 260
Recruitment Details The study was performed from 06 Sept 2007 to 05 Sept 2008. A total of 16 medical clinics participated in the study.
Pre-assignment Details Subjects underwent a 5- to 9-week screening washout period to determine study eligibility and to wash-out patients of all lipid-lowering therapies; patients were required to have low-density lipoprotein cholesterol (LDL-C) between 100 and 190 mg/dL (average of 2 visits during screening) and hepatic fat less than 6.2% for randomization.
Arm/Group Title Placebo AEGR-733 2.5 mg AEGR-733 5 mg AEGR-733 7.5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 5 mg + Fenofibrate 145 mg AEGR-733 5 mg + Ezetimibe 10 mg
Hide Arm/Group Description Oral placebo every 4 weeks for 12 weeks Oral lomitapide 2.5 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg every 4 weeks for 12 weeks Oral lomitapide 7.5 mg every 4 weeks for 12 weeks Oral lomitapide 10 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
Period Title: Overall Study
Started 33 34 34 34 35 28 33 29
Completed 31 25 24 29 21 23 28 25
Not Completed 2 9 10 5 14 5 5 4
Reason Not Completed
Adverse Event             1             7             8             5             11             4             4             2
Lost to Follow-up             0             1             0             0             0             0             0             0
Withdrawal by Subject             1             1             2             0             3             1             0             2
Inclusion/exclusion criteria not met             0             0             0             0             0             0             1             0
Arm/Group Title Placebo AEGR-733 2.5 mg AEGR-733 5 mg AEGR-733 7.5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 5 mg + Fenofibrate 145 mg AEGR-733 5 mg + Ezetimibe 10 mg Total
Hide Arm/Group Description Oral placebo every 4 weeks for 12 weeks Oral lomitapide 2.5 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg every 4 weeks for 12 weeks Oral lomitapide 7.5 mg every 4 weeks for 12 weeks Oral lomitapide 10 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 33 34 34 34 35 28 33 29 260
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 34 participants 34 participants 34 participants 35 participants 28 participants 33 participants 29 participants 260 participants
47.8  (12.53) 51.5  (12.99) 48.6  (11.3) 49.0  (10.24) 52.9  (11.97) 53.9  (8.92) 54.0  (11.95) 52.7  (9.36) 51.3  (11.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 34 participants 34 participants 34 participants 35 participants 28 participants 33 participants 29 participants 260 participants
Female
19
  57.6%
18
  52.9%
16
  47.1%
17
  50.0%
20
  57.1%
17
  60.7%
17
  51.5%
12
  41.4%
136
  52.3%
Male
14
  42.4%
16
  47.1%
18
  52.9%
17
  50.0%
15
  42.9%
11
  39.3%
16
  48.5%
17
  58.6%
124
  47.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 34 participants 34 participants 34 participants 35 participants 28 participants 33 participants 29 participants 260 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.0%
0
   0.0%
0
   0.0%
1
   2.9%
0
   0.0%
0
   0.0%
1
   3.0%
0
   0.0%
3
   1.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  15.2%
9
  26.5%
8
  23.5%
9
  26.5%
8
  22.9%
4
  14.3%
7
  21.2%
5
  17.2%
55
  21.2%
White
24
  72.7%
21
  61.8%
24
  70.6%
23
  67.6%
22
  62.9%
22
  78.6%
24
  72.7%
22
  75.9%
182
  70.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   9.1%
4
  11.8%
2
   5.9%
1
   2.9%
5
  14.3%
2
   7.1%
1
   3.0%
2
   6.9%
20
   7.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 34 participants 34 participants 34 participants 35 participants 28 participants 33 participants 29 participants 260 participants
33 34 34 34 35 28 33 29 260
1.Primary Outcome
Title Absolute Change From Baseline in Percent Hepatic Fat
Hide Description Absolute change from Baseline in percent hepatic fat
Time Frame Baseline and 12 weeks on study drug
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Placebo AEGR-733 5 mg
Hide Arm/Group Description:
Oral placebo every 4 weeks for 12 weeks
Oral lomitapide 5 mg every 4 weeks for 12 weeks
Overall Number of Participants Analyzed 31 24
Mean (Standard Deviation)
Unit of Measure: Percent of Hepatic Fat
0.03  (1.814) 4.72  (6.297)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, AEGR-733 5 mg
Comments One-way analysis of variance (ANOVA) to compare the absolute change from baseline to Week 12 in percent hepatic fat between AEGR-755 5 mg and placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.68
Confidence Interval (2-Sided) 95%
2.30 to 7.07
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Absolute Change From Baseline in Percent Hepatic Fat
Hide Description Absolute change from Baseline in percent hepatic fat
Time Frame Baseline and 12 weeks on study drug
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Placebo AEGR-733 2.5 mg AEGR-733 5 mg AEGR-733 7.5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 5 mg + Fenofibrate 145 mg AEGR-733 5 mg + Ezetimibe 10 mg
Hide Arm/Group Description:
Oral placebo every 4 weeks for 12 weeks
Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
Oral lomitapide 5 mg every 4 weeks for 12 weeks
Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
Oral lomitapide 10 mg every 4 weeks for 12 weeks
Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
Overall Number of Participants Analyzed 31 27 24 27 20 23 26 26
Mean (Standard Deviation)
Unit of Measure: Percent of Hepatic Fat
0.03  (1.814) 4.95  (7.122) 4.72  (6.297) 3.94  (5.763) 7.86  (9.515) 3.68  (5.365) 7.70  (9.390) 7.55  (6.230)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, AEGR-733 2.5 mg
Comments One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments (All comparisons)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.92
Confidence Interval (2-Sided) 95%
2.27 to 7.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, AEGR-733 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments (All comparisons)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.68
Confidence Interval (2-Sided) 95%
2.30 to 7.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, AEGR-733 7.5 mg
Comments One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments (All comparisons)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.91
Confidence Interval (2-Sided) 95%
1.73 to 6.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, AEGR-733 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments (All comparisons)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.82
Confidence Interval (2-Sided) 95%
4.31 to 11.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, AEGR-733 5 mg + Atorvastatin 20 mg
Comments One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments (All comparisons)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.65
Confidence Interval (2-Sided) 95%
1.58 to 5.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, AEGR-733 5 mg + Fenofibrate 145 mg
Comments One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments (All comparisons)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.66
Confidence Interval (2-Sided) 95%
4.22 to 11.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, AEGR-733 5 mg + Ezetimibe 10 mg
Comments One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments (All comparisons)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.51
Confidence Interval (2-Sided) 95%
5.16 to 9.86
Estimation Comments [Not Specified]
Time Frame From 10 days before the first dose to 30 days post last dose.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo AEGR-733 2.5 mg AEGR-733 5 mg AEGR-733 7.5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 5 mg + Fenofibrate 145 mg AEGR-733 5 mg + Ezetimibe 10 mg
Hide Arm/Group Description Oral placebo every 4 weeks for 12 weeks Oral lomitapide 2.5 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg every 4 weeks for 12 weeks Oral lomitapide 7.5 mg every 4 weeks for 12 weeks Oral lomitapide 10 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
All-Cause Mortality
Placebo AEGR-733 2.5 mg AEGR-733 5 mg AEGR-733 7.5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 5 mg + Fenofibrate 145 mg AEGR-733 5 mg + Ezetimibe 10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo AEGR-733 2.5 mg AEGR-733 5 mg AEGR-733 7.5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 5 mg + Fenofibrate 145 mg AEGR-733 5 mg + Ezetimibe 10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   1/34 (2.94%)   0/34 (0.00%)   0/34 (0.00%)   2/35 (5.71%)   0/28 (0.00%)   0/33 (0.00%)   0/29 (0.00%) 
Gastrointestinal disorders                 
Inflammatory Bowel Disease * 1  0/33 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%)  0/28 (0.00%)  0/33 (0.00%)  0/29 (0.00%) 
General disorders                 
Chest Pain * 1  0/33 (0.00%)  1/34 (2.94%)  0/34 (0.00%)  0/34 (0.00%)  0/35 (0.00%)  0/28 (0.00%)  0/33 (0.00%)  0/29 (0.00%) 
Injury, poisoning and procedural complications                 
Ankle Fracture * 1  0/33 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%)  0/28 (0.00%)  0/33 (0.00%)  0/29 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA, version 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo AEGR-733 2.5 mg AEGR-733 5 mg AEGR-733 7.5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 5 mg + Fenofibrate 145 mg AEGR-733 5 mg + Ezetimibe 10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/33 (60.61%)   31/34 (91.18%)   30/34 (88.24%)   29/34 (85.29%)   32/35 (91.43%)   24/28 (85.71%)   29/33 (87.88%)   25/29 (86.21%) 
Gastrointestinal disorders                 
Diarrhoea * 1  4/33 (12.12%)  16/34 (47.06%)  15/34 (44.12%)  16/34 (47.06%)  23/35 (65.71%)  14/28 (50.00%)  15/33 (45.45%)  19/29 (65.52%) 
Nausea * 1  1/33 (3.03%)  2/34 (5.88%)  8/34 (23.53%)  8/34 (23.53%)  13/35 (37.14%)  5/28 (17.86%)  8/33 (24.24%)  5/29 (17.24%) 
Flatulence * 1  2/33 (6.06%)  6/34 (17.65%)  3/34 (8.82%)  1/34 (2.94%)  2/35 (5.71%)  5/28 (17.86%)  1/33 (3.03%)  6/29 (20.69%) 
Abdominal Pain Upper * 1  2/33 (6.06%)  2/34 (5.88%)  2/34 (5.88%)  5/34 (14.71%)  4/35 (11.43%)  2/28 (7.14%)  2/33 (6.06%)  1/29 (3.45%) 
Abdominal Distension * 1  2/33 (6.06%)  2/34 (5.88%)  3/34 (8.82%)  4/34 (11.76%)  1/35 (2.86%)  2/28 (7.14%)  2/33 (6.06%)  2/29 (6.90%) 
Vomiting * 1  1/33 (3.03%)  2/34 (5.88%)  3/34 (8.82%)  1/34 (2.94%)  4/35 (11.43%)  2/28 (7.14%)  5/33 (15.15%)  0/29 (0.00%) 
Dyspepsia * 1  1/33 (3.03%)  4/34 (11.76%)  1/34 (2.94%)  1/34 (2.94%)  2/35 (5.71%)  2/28 (7.14%)  2/33 (6.06%)  4/29 (13.79%) 
Constipation * 1  3/33 (9.09%)  0/34 (0.00%)  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%)  2/28 (7.14%)  4/33 (12.12%)  2/29 (6.90%) 
Abdominal Pain * 1  2/33 (6.06%)  2/34 (5.88%)  3/34 (8.82%)  1/34 (2.94%)  3/35 (8.57%)  1/28 (3.57%)  0/33 (0.00%)  0/29 (0.00%) 
Abdominal Discomfort * 1  0/33 (0.00%)  0/34 (0.00%)  1/34 (2.94%)  0/34 (0.00%)  2/35 (5.71%)  2/28 (7.14%)  1/33 (3.03%)  0/29 (0.00%) 
Gastrointestinal Pain * 1  0/33 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  0/35 (0.00%)  2/28 (7.14%)  1/33 (3.03%)  0/29 (0.00%) 
Eruction * 1  0/33 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  2/35 (5.71%)  0/28 (0.00%)  0/33 (0.00%)  0/29 (0.00%) 
General disorders                 
Fatigue * 1  2/33 (6.06%)  3/34 (8.82%)  5/34 (14.71%)  3/34 (8.82%)  3/35 (8.57%)  1/28 (3.57%)  3/33 (9.09%)  1/29 (3.45%) 
Pyrexia * 1  0/33 (0.00%)  0/34 (0.00%)  1/34 (2.94%)  0/34 (0.00%)  1/35 (2.86%)  2/28 (7.14%)  2/33 (6.06%)  0/29 (0.00%) 
Influenza Like Illness * 1  0/33 (0.00%)  0/34 (0.00%)  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%)  0/28 (0.00%)  2/33 (6.06%)  0/29 (0.00%) 
Immune system disorders                 
Seasonal Allergy * 1  0/33 (0.00%)  0/34 (0.00%)  1/34 (2.94%)  2/34 (5.88%)  1/35 (2.86%)  0/28 (0.00%)  2/33 (6.06%)  0/29 (0.00%) 
Infections and infestations                 
Upper Respiratory Tract Infection * 1  1/33 (3.03%)  1/34 (2.94%)  0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%)  0/28 (0.00%)  4/33 (12.12%)  0/29 (0.00%) 
Nasopharyngitis * 1  1/33 (3.03%)  1/34 (2.94%)  0/34 (0.00%)  1/34 (2.94%)  1/35 (2.86%)  3/28 (10.71%)  0/33 (0.00%)  1/29 (3.45%) 
Influenza * 1  0/33 (0.00%)  1/34 (2.94%)  2/34 (5.88%)  0/34 (0.00%)  1/35 (2.86%)  0/28 (0.00%)  0/33 (0.00%)  2/29 (6.90%) 
Investigations                 
Alanine Aminotransferase Increased * 1  0/33 (0.00%)  3/34 (8.82%)  2/34 (5.88%)  1/34 (2.94%)  1/35 (2.86%)  0/28 (0.00%)  4/33 (12.12%)  0/29 (0.00%) 
Aspartate Aminotransferase Increased * 1  0/33 (0.00%)  2/34 (5.88%)  1/34 (2.94%)  1/34 (2.94%)  1/35 (2.86%)  0/28 (0.00%)  4/33 (12.12%)  0/29 (0.00%) 
White Blood Cell Count Decreased * 1  1/33 (3.03%)  2/34 (5.88%)  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%)  0/28 (0.00%)  1/33 (3.03%)  0/29 (0.00%) 
Protein Urine * 1  0/33 (0.00%)  0/34 (0.00%)  2/34 (5.88%)  0/34 (0.00%)  1/35 (2.86%)  0/28 (0.00%)  0/33 (0.00%)  0/29 (0.00%) 
C-reactive Protein * 1  0/33 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  0/35 (0.00%)  2/28 (7.14%)  0/33 (0.00%)  0/29 (0.00%) 
Metabolism and nutrition disorders                 
Decreased Appetite * 1  0/33 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  2/35 (5.71%)  1/28 (3.57%)  1/33 (3.03%)  0/29 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Back Pain * 1  2/33 (6.06%)  1/34 (2.94%)  2/34 (5.88%)  2/34 (5.88%)  1/35 (2.86%)  0/28 (0.00%)  1/33 (3.03%)  2/29 (6.90%) 
Myalgia * 1  0/33 (0.00%)  1/34 (2.94%)  2/34 (5.88%)  1/34 (2.94%)  0/35 (0.00%)  1/28 (3.57%)  1/33 (3.03%)  2/29 (6.90%) 
Arthralgia * 1  0/33 (0.00%)  0/34 (0.00%)  4/34 (11.76%)  0/34 (0.00%)  1/35 (2.86%)  0/28 (0.00%)  0/33 (0.00%)  2/29 (6.90%) 
Musculoskeletal Pain * 1  0/33 (0.00%)  0/34 (0.00%)  2/34 (5.88%)  0/34 (0.00%)  0/35 (0.00%)  0/28 (0.00%)  0/33 (0.00%)  0/29 (0.00%) 
Nervous system disorders                 
Headache * 1  4/33 (12.12%)  2/34 (5.88%)  6/34 (17.65%)  8/34 (23.53%)  1/35 (2.86%)  3/28 (10.71%)  4/33 (12.12%)  4/29 (13.79%) 
Dizziness * 1  1/33 (3.03%)  1/34 (2.94%)  2/34 (5.88%)  0/34 (0.00%)  1/35 (2.86%)  1/28 (3.57%)  0/33 (0.00%)  0/29 (0.00%) 
Psychiatric disorders                 
Insomnia * 1  3/33 (9.09%)  0/34 (0.00%)  2/34 (5.88%)  1/34 (2.94%)  0/35 (0.00%)  1/28 (3.57%)  0/33 (0.00%)  4/29 (13.79%) 
Reproductive system and breast disorders                 
Dysmenorrhoea * 1  0/33 (0.00%)  0/34 (0.00%)  2/34 (5.88%)  0/34 (0.00%)  0/35 (0.00%)  0/28 (0.00%)  0/33 (0.00%)  0/29 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Cough * 1  0/33 (0.00%)  2/34 (5.88%)  0/34 (0.00%)  1/34 (2.94%)  2/35 (5.71%)  0/28 (0.00%)  1/33 (3.03%)  2/29 (6.90%) 
Oropharyngeal Pain * 1  0/33 (0.00%)  1/34 (2.94%)  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%)  0/28 (0.00%)  2/33 (6.06%)  0/29 (0.00%) 
Skin and subcutaneous tissue disorders                 
Rash * 1  0/33 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  0/35 (0.00%)  0/28 (0.00%)  3/33 (9.09%)  1/29 (3.45%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA, version 14.0
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.
PI can publish after sponsor reviews the proposed publication. PI must give sponsor at least 60 days to review before publication. PI needs to obtain sponsor's prior written consent to publish confidential information, which shall not be unreasonably withheld or delayed. The PI shall, upon request of sponsor, delete any confidential information which would prejudice the securing of adequate intellectual property protection from the publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mark Sumeray, MD, Chief Medical Officer
Organization: Aegerion Pharmaceuticals
Phone: 617-500-7867
Layout table for additonal information
Responsible Party: William J Sasiela, PhD Chief Medical Officer, Aegerion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00559962    
Other Study ID Numbers: AEGR-733-004
First Submitted: November 15, 2007
First Posted: November 19, 2007
Results First Submitted: January 18, 2013
Results First Posted: February 22, 2013
Last Update Posted: February 23, 2018