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Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents

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ClinicalTrials.gov Identifier: NCT00359281
Recruitment Status : Completed
First Posted : August 2, 2006
Results First Posted : March 4, 2014
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Healthy
Interventions Drug: atorvastatin
Drug: simvastatin
Drug: ezetimibe
Drug: fenofibrate
Drug: dextromethorphan
Drug: Extended Release Niacin
Enrollment 125
Recruitment Details The study was performed from 19 May 2006 to 20 November 2007 at 1 medical clinic within the United States.
Pre-assignment Details  
Arm/Group Title Atorvastatin 20 mg + Lomitapide 10 mg Simvastatin 20 mg + Lomitapide 10 mg Ezetimibe 10 mg + Lomitapide 10 mg Rosuvastatin 20 mg + Lomitapide 10 mg Fenofibrate 145 mg + Lomitapide 10 mg Atorvastatin 20 mg + Lomitapide 60 mg Rosuvastatin 20 mg + Lomitapide 60 mg Dextrometh-rophan 30 mg + Lomitapide 60 mg ER Niacin 1000 mg + Lomitapide 10 mg
Hide Arm/Group Description One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
Period Title: Overall Study
Started 16 15 10 10 10 15 18 15 20
Completed 15 15 10 10 10 15 16 15 20
Not Completed 1 0 0 0 0 0 2 0 0
Reason Not Completed
Adverse Event             1             0             0             0             0             0             1             0             0
Withdrawal by Subject             0             0             0             0             0             0             1             0             0
Arm/Group Title Atorvastatin 20 mg + Lomitapide 10 mg Simvastatin 20 mg + Lomitapide 10 mg Ezetimibe 10 mg + Lomitapide 10 mg Rosuvastatin 20 mg + Lomitapide 10 mg Fenofibrate 145 mg + Lomitapide 10 mg Atorvastatin 20 mg + Lomitapide 60 mg Rosuvastatin 20 mg + Lomitapide 60 mg Dextrometh-rophan 30 mg + Lomitapide 60 mg ER Niacin 1000 mg + Lomitapide 10 mg Total
Hide Arm/Group Description One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg Total of all reporting groups
Overall Number of Baseline Participants 16 15 10 10 10 15 18 15 20 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 15 participants 10 participants 10 participants 10 participants 15 participants 18 participants 15 participants 20 participants 129 participants
26  (7) 29  (12) 29  (9) 31  (13) 24  (3) 27  (8) 31  (13) 27  (9) 29  (11) 28  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 10 participants 10 participants 10 participants 15 participants 18 participants 15 participants 20 participants 129 participants
Female
7
  43.8%
10
  66.7%
3
  30.0%
2
  20.0%
2
  20.0%
5
  33.3%
9
  50.0%
6
  40.0%
9
  45.0%
53
  41.1%
Male
9
  56.3%
5
  33.3%
7
  70.0%
8
  80.0%
8
  80.0%
10
  66.7%
9
  50.0%
9
  60.0%
11
  55.0%
76
  58.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 10 participants 10 participants 10 participants 15 participants 18 participants 15 participants 20 participants 129 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%
0
   0.0%
Asian
3
  18.8%
2
  13.3%
0
   0.0%
0
   0.0%
1
  10.0%
3
  20.0%
1
   5.6%
3
  20.0%
2
  10.0%
15
  11.6%
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%
0
   0.0%
Black or African American
2
  12.5%
2
  13.3%
1
  10.0%
4
  40.0%
2
  20.0%
1
   6.7%
5
  27.8%
2
  13.3%
4
  20.0%
23
  17.8%
White
11
  68.8%
11
  73.3%
8
  80.0%
5
  50.0%
7
  70.0%
6
  40.0%
11
  61.1%
10
  66.7%
13
  65.0%
82
  63.6%
More than one race
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
5
  33.3%
1
   5.6%
0
   0.0%
1
   5.0%
8
   6.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 15 participants 10 participants 10 participants 10 participants 15 participants 18 participants 15 participants 20 participants 129 participants
16 15 10 10 10 15 18 15 20 129
1.Primary Outcome
Title Area Under Concentration-time Curve From 0 to Last Measureable Concentration (AUC0-t) Atorvastatin Acid (Lomitapide 10 mg)
Hide Description Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 10 mg)
Time Frame 0 to 24 hour
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Pharmacokinetic
Arm/Group Title Atorvastatin 20 mg + Lomitapide 10 mg
Hide Arm/Group Description:
One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
Overall Number of Participants Analyzed 15
Geometric Mean (90% Confidence Interval)
Unit of Measure: Ratio
110.97
(98.42 to 125.12)
2.Primary Outcome
Title AUC0-t Simvastatin
Hide Description Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin
Time Frame 0 to 24 hours
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Pharmacokinetic
Arm/Group Title Simvastatin 20 mg + Lomitapide 10 mg
Hide Arm/Group Description:
One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
Overall Number of Participants Analyzed 15
Geometric Mean (90% Confidence Interval)
Unit of Measure: Ratio
162.25
(143.19 to 183.86)
3.Primary Outcome
Title AUC0-t Simvastatin Acid
Hide Description Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin acid
Time Frame 0 to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic
Arm/Group Title Simvastatin 20 mg + Lomitapide 10 mg
Hide Arm/Group Description:
One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
Overall Number of Participants Analyzed 15
Geometric Mean (90% Confidence Interval)
Unit of Measure: Ratio
138.76
(109.65 to 175.61)
4.Primary Outcome
Title AUC0-t Total Ezetimibe
Hide Description Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for total ezetimibe
Time Frame 0 to 24 hours
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Pharmacokinetic
Arm/Group Title Ezetimibe 10 mg + Lomitapide 10 mg
Hide Arm/Group Description:
One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
Overall Number of Participants Analyzed 10
Geometric Mean (90% Confidence Interval)
Unit of Measure: Ratio
105.71
(92.62 to 120.66)
5.Primary Outcome
Title AUC0-t Rosuvastatin (Lomitapide 10 mg)
Hide Description Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 10 mg)
Time Frame 0 to 24 hours
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Hide Analysis Population Description
Pharmacokinetic
Arm/Group Title Rosuvastatin 20 mg + Lomitapide 10 mg
Hide Arm/Group Description:
One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
Overall Number of Participants Analyzed 10
Geometric Mean (90% Confidence Interval)
Unit of Measure: Ratio
102.05
(86.00 to 121.10)
6.Primary Outcome
Title AUC0-t Fenofibric Acid
Hide Description Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for fenofibric acid
Time Frame 0 to 24 hours
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Pharmacokinetic
Arm/Group Title Fenofibrate 145 mg + Lomitapide 10 mg
Hide Arm/Group Description:
One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
Overall Number of Participants Analyzed 10
Geometric Mean (90% Confidence Interval)
Unit of Measure: Ratio
89.62
(82.76 to 97.04)
7.Primary Outcome
Title AUC0-t Atorvastatin Acid (Lomitapide 60 mg)
Hide Description Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 60 mg)
Time Frame 0 to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic
Arm/Group Title Atorvastatin 20 mg + Lomitapide 60 mg
Hide Arm/Group Description:
One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
Overall Number of Participants Analyzed 15
Geometric Mean (90% Confidence Interval)
Unit of Measure: Ratio
152.32
(133.76 to 173.45)
8.Primary Outcome
Title AUC0-t Rosuvastatin (Lomitapide 60 mg)
Hide Description Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 60 mg)
Time Frame 0 to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic
Arm/Group Title Rosuvastatin 20 mg + Lomitapide 60 mg
Hide Arm/Group Description:
One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
Overall Number of Participants Analyzed 15
Geometric Mean (90% Confidence Interval)
Unit of Measure: Ratio
132.21
(111.56 to 156.70)
9.Primary Outcome
Title AUC0-t Nicotinic Acid
Hide Description Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinic acid
Time Frame 0 to 24 hours
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Pharmacokinetic
Arm/Group Title ER Niacin 1000 mg + Lomitapide 10 mg
Hide Arm/Group Description:
One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
Overall Number of Participants Analyzed 20
Geometric Mean (90% Confidence Interval)
Unit of Measure: Ratio
110.22
(78.28 to 155.18)
10.Primary Outcome
Title AUC0-t Nicotinuric Acid
Hide Description Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinuric acid
Time Frame 0 to 24 hours
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Pharmacokinetic
Arm/Group Title ER Niacin 1000 mg + Lomitapide 10 mg
Hide Arm/Group Description:
One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
Overall Number of Participants Analyzed 20
Geometric Mean (90% Confidence Interval)
Unit of Measure: Ratio
79.15
(59.82 to 104.72)
11.Secondary Outcome
Title Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Hide Description Percent change from Baseline in LDL-C
Time Frame Baseline to Day 8
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Intention To Treat
Arm/Group Title Atorvastatin 20 mg + Lomitapide 10 mg Simvastatin 20 mg + Lomitapide 10 mg Ezetimibe 10 mg + Lomitapide 10 mg Rosuvastatin 20 mg + Lomitapide 10 mg Fenofibrate 145 mg + Lomitapide 10 mg Atorvastatin 20 mg + Lomitapide 60 mg Rosuvastatin 20 mg + Lomitapide 60 mg Dextrometh-rophan 30 mg + Lomitapide 60 mg ER Niacin 1000 mg + Lomitapide 10 mg
Hide Arm/Group Description:
One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
Overall Number of Participants Analyzed 16 15 10 10 10 15 18 15 20
Mean (Standard Deviation)
Unit of Measure: Percent Change
-30.99  (14.47) -26.43  (17.77) -28.36  (12.53) -41.74  (10.37) -20.12  (25.56) -66.02  (15.18) -63.20  (18.59) -46.07  (33.12) -20.89  (15.17)
Time Frame From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atorvastatin 20 mg + Lomitapide 10 mg Simvastatin 20 mg + Lomitapide 10 mg Ezetimibe 10 mg + Lomitapide 10 mg Rosuvastatin 20 mg + Lomitapide 10 mg Fenofibrate 145 mg + Lomitapide 10 mg Atorvastatin 20 mg + Lomitapide 60 mg Rosuvastatin 20 mg + Lomitapide 60 mg Dextrometh-rophan 30 mg + Lomitapide 60 mg ER Niacin 1000 mg + Lomitapide 10 mg
Hide Arm/Group Description One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
All-Cause Mortality
Atorvastatin 20 mg + Lomitapide 10 mg Simvastatin 20 mg + Lomitapide 10 mg Ezetimibe 10 mg + Lomitapide 10 mg Rosuvastatin 20 mg + Lomitapide 10 mg Fenofibrate 145 mg + Lomitapide 10 mg Atorvastatin 20 mg + Lomitapide 60 mg Rosuvastatin 20 mg + Lomitapide 60 mg Dextrometh-rophan 30 mg + Lomitapide 60 mg ER Niacin 1000 mg + Lomitapide 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 (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Atorvastatin 20 mg + Lomitapide 10 mg Simvastatin 20 mg + Lomitapide 10 mg Ezetimibe 10 mg + Lomitapide 10 mg Rosuvastatin 20 mg + Lomitapide 10 mg Fenofibrate 145 mg + Lomitapide 10 mg Atorvastatin 20 mg + Lomitapide 60 mg Rosuvastatin 20 mg + Lomitapide 60 mg Dextrometh-rophan 30 mg + Lomitapide 60 mg ER Niacin 1000 mg + Lomitapide 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 (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/15 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/15 (0.00%)   0/18 (0.00%)   0/15 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atorvastatin 20 mg + Lomitapide 10 mg Simvastatin 20 mg + Lomitapide 10 mg Ezetimibe 10 mg + Lomitapide 10 mg Rosuvastatin 20 mg + Lomitapide 10 mg Fenofibrate 145 mg + Lomitapide 10 mg Atorvastatin 20 mg + Lomitapide 60 mg Rosuvastatin 20 mg + Lomitapide 60 mg Dextrometh-rophan 30 mg + Lomitapide 60 mg ER Niacin 1000 mg + Lomitapide 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 (%) Affected / at Risk (%)
Total   8/16 (50.00%)   8/15 (53.33%)   6/10 (60.00%)   3/10 (30.00%)   6/10 (60.00%)   12/15 (80.00%)   15/18 (83.33%)   11/15 (73.33%)   18/20 (90.00%) 
Cardiac disorders                   
Palpitations * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  2/20 (10.00%) 
Gastrointestinal disorders                   
Diarrhoea * 1  3/16 (18.75%)  4/15 (26.67%)  1/10 (10.00%)  0/10 (0.00%)  3/10 (30.00%)  7/15 (46.67%)  9/18 (50.00%)  4/15 (26.67%)  2/20 (10.00%) 
Nausea * 1  1/16 (6.25%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  2/10 (20.00%)  2/15 (13.33%)  3/18 (16.67%)  3/15 (20.00%)  2/20 (10.00%) 
Abdominal discomfort * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  5/15 (33.33%)  2/18 (11.11%)  5/15 (33.33%)  1/20 (5.00%) 
Flatulence * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  3/15 (20.00%)  2/18 (11.11%)  1/15 (6.67%)  2/20 (10.00%) 
Abnormal faeces * 1  1/16 (6.25%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  2/15 (13.33%)  0/18 (0.00%)  1/15 (6.67%)  3/20 (15.00%) 
Abdominal pain upper * 1  0/16 (0.00%)  2/15 (13.33%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  4/20 (20.00%) 
Abdominal distension * 1  0/16 (0.00%)  0/15 (0.00%)  3/10 (30.00%)  1/10 (10.00%)  0/10 (0.00%)  0/15 (0.00%)  1/18 (5.56%)  1/15 (6.67%)  0/20 (0.00%) 
Vomiting * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/15 (6.67%)  2/18 (11.11%)  0/15 (0.00%)  1/20 (5.00%) 
Constipation * 1  0/16 (0.00%)  1/15 (6.67%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  1/15 (6.67%)  0/18 (0.00%)  0/15 (0.00%)  0/20 (0.00%) 
Dyspepsia * 1  1/16 (6.25%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/20 (0.00%) 
Eructation * 1  1/16 (6.25%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/20 (0.00%) 
Faeces discoloured * 1  1/16 (6.25%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/20 (0.00%) 
Gastrooesophageal reflux disease * 1  1/16 (6.25%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/20 (0.00%) 
Faeces hard * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/20 (0.00%) 
Abdominal pain * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/20 (0.00%) 
Gastric dilatation * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/20 (0.00%) 
Haemorrhoids * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/20 (0.00%) 
General disorders                   
Fatigue * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  6/15 (40.00%)  0/20 (0.00%) 
Chills * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  3/20 (15.00%) 
Pyrexia * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  2/15 (13.33%)  0/18 (0.00%)  0/15 (0.00%)  0/20 (0.00%) 
Infusion site haematoma * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/15 (6.67%)  0/18 (0.00%)  0/15 (0.00%)  0/20 (0.00%) 
Infusion site pain * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/20 (0.00%) 
Malaise * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/20 (0.00%) 
Injury, poisoning and procedural complications                   
Laceration * 1  0/16 (0.00%)  0/15 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Arthralgia * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/20 (0.00%) 
Back pain * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  1/18 (5.56%)  1/15 (6.67%)  0/20 (0.00%) 
Musculoskeletal chest pain * 1  1/16 (6.25%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/20 (0.00%) 
Nervous system disorders                   
Headache * 1  0/16 (0.00%)  2/15 (13.33%)  1/10 (10.00%)  2/10 (20.00%)  0/10 (0.00%)  1/15 (6.67%)  1/18 (5.56%)  0/15 (0.00%)  3/20 (15.00%) 
Paraesthesia * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  7/20 (35.00%) 
Dizziness * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/15 (0.00%)  1/18 (5.56%)  2/15 (13.33%)  2/20 (10.00%) 
Dysgeusia * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/15 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/20 (0.00%) 
Renal and urinary disorders                   
Chromaturia * 1  1/16 (6.25%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Dyspnoea * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  3/20 (15.00%) 
Skin and subcutaneous tissue disorders                   
Pruritus * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  7/20 (35.00%) 
Rash * 1  0/16 (0.00%)  1/15 (6.67%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/20 (0.00%) 
Vascular disorders                   
Flushing * 1  0/16 (0.00%)  0/15 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  12/20 (60.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 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.
 
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
EMail: msumeray@aegerion.com
Layout table for additonal information
Responsible Party: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00359281    
Other Study ID Numbers: AEGR-733-002
Aegerion 002 PK study
First Submitted: July 31, 2006
First Posted: August 2, 2006
Results First Submitted: January 18, 2013
Results First Posted: March 4, 2014
Last Update Posted: February 23, 2018