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Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects.

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ClinicalTrials.gov Identifier: NCT02080455
Recruitment Status : Completed
First Posted : March 6, 2014
Results First Posted : March 10, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Effect of Atorvastatin on the Pharmacokinetics of Lomitapide
Interventions Drug: lomitapide
Drug: Atorvastatin
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lomitapide & Atorvastatin - Taken Together Lomitapide & Atorvastatin - Approx. 12 Hours Between
Hide Arm/Group Description

2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 & Day 15)

11 single oral doses of atorvastatin (80 mg) (Day 11 through day 21)

lomitapide: 20 mg dose

Atorvastatin: 80 mg

2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 & Day 15)

11 single oral doses of atorvastatin (80 mg) (Day 12 through day 22)

lomitapide: 20 mg dose

Atorvastatin: 80 mg

Period Title: Overall Study
Started 16 16
Completed 16 16
Not Completed 0 0
Arm/Group Title Lomitapide & Atorvastatin - Taken Together Lomitapide & Atorvastatin - Approx. 12 Hours Between Total
Hide Arm/Group Description

2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 & Day 15)

11 single oral doses of atorvastatin (80 mg) (Day 11 through day 21)

lomitapide: 20 mg dose

Atorvastatin: 80 mg

2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 & Day 15)

11 single oral doses of atorvastatin (80 mg) (Day 12 through day 22)

lomitapide: 20 mg dose

Atorvastatin: 80 mg

Total of all reporting groups
Overall Number of Baseline Participants 16 16 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
16
 100.0%
32
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 16 participants 32 participants
41  (9.1) 39  (9.5) 40  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Female
8
  50.0%
8
  50.0%
16
  50.0%
Male
8
  50.0%
8
  50.0%
16
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Hispanic or Latino
1
   6.3%
12
  75.0%
13
  40.6%
Not Hispanic or Latino
15
  93.8%
4
  25.0%
19
  59.4%
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 16 participants 16 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   6.3%
1
   3.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  50.0%
2
  12.5%
10
  31.3%
White
8
  50.0%
13
  81.3%
21
  65.6%
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 16 participants 16 participants 32 participants
16 16 32
1.Primary Outcome
Title Cmax
Hide Description Maximum observed plasma concentration of lomitapide and its 2 primary metabolites (M1 & M3), following administration of lomitapide alone and coadministered with atorvastatin simultaneously (Arm 1)
Time Frame Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data.
Arm/Group Title PK of Lomitapide (Lomitapide Alone) PK of Lomitapide (Coadministered Simultaneously) PK of M1 (Lomitapide Alone) PK of M1 (Coadministered Simultaneously) PK of M3 (Lomitapide Alone) PK of M3 (Coadministered Simultaneously)
Hide Arm/Group Description:
PK of lomitapide following administration of lomitapide alone
PK of lomitapide following administration of lomitapide coadministered with atorvastatin simultaneously
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with atorvastatin simultaneously
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with atorvastatin simultaneously
Overall Number of Participants Analyzed 16 16 16 16 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
0.940
(34.5%)
2.00
(52.9%)
2.24
(22.8%)
2.11
(31.9%)
32.3
(40.6%)
27.2
(62.0%)
2.Primary Outcome
Title Tmax
Hide Description Time to reach maximum observed plasma concentration of lomitapide and its 2 primary metabolites (M1 & M3), following administration of lomitapide alone and coadministered with atorvastatin simultaneously (Arm 1)
Time Frame Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population consisted of all subjects who received at least one dose of study drug and had evaluable PK data.
Arm/Group Title PK of Lomitapide (Lomitapide Alone) PK of Lomitapide (Coadministered Simultaneously) PK of M1 (Lomitapide Alone) PK of M1 (Coadministered Simultaneously) PK of M3 (Lomitapide Alone) PK of M3 (Coadministered Simultaneously)
Hide Arm/Group Description:
PK of lomitapide following administration of lomitapide alone
PK of lomitapide following administration of lomitapide coadministered with atorvastatin simultaneously
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with atorvastatin simultaneously
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with atorvastatin simultaneously
Overall Number of Participants Analyzed 16 16 16 16 16 16
Median (Full Range)
Unit of Measure: hr
6.00
(3.00 to 10.0)
10.0
(3.00 to 23.8)
6.02
(4.00 to 10.0)
10.0
(4.00 to 23.8)
4.00
(3.00 to 12.0)
6.00
(3.00 to 23.8)
3.Primary Outcome
Title AUC0-t
Hide Description Area under the concentration-time curve from zero to the last quantifiable concentration of lomitapide and its 2 primary metabolites (M1 & M3), following administration of lomitapide alone and coadministered with atorvastatin simultaneously (Arm 1)
Time Frame Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population consisted of all subjects who received at least one dose of study drug and had evaluable PK data.
Arm/Group Title PK of Lomitapide (Lomitapide Alone) PK of Lomitapide (Coadministered Simultaneously) PK of M1 (Lomitapide Alone) PK of M1 (Coadministered Simultaneously) PK of M3 (Lomitapide Alone) PK of M3 (Coadministered Simultaneously)
Hide Arm/Group Description:
PK of lomitapide following administration of lomitapide alone
PK of lomitapide following administration of lomitapide coadministered with atorvastatin simultaneously
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with atorvastatin simultaneously
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with atorvastatin simultaneously
Overall Number of Participants Analyzed 16 16 16 16 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
36.4
(38.4%)
71.5
(45.3%)
76.8
(34.4%)
76.3
(36.0%)
434
(65.5%)
475
(55.0%)
4.Primary Outcome
Title AUC0-∞
Hide Description Area under the concentration-time curve from zero to infinity of lomitapide and its 2 primary metabolites (M1 & M3), following administration of lomitapide alone and coadministered with atorvastatin simultaneously (Arm 1)
Time Frame Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population consisted of all subjects who received at least one dose of study drug and had evaluable PK data. 2 subjects were removed from formal statistical analysis of "PK of M3 (Lomitapide alone)" due to missing value of AUC0-∞ for Analyte M3.
Arm/Group Title PK of Lomitapide (Lomitapide Alone) PK of Lomitapide (Coadministered Simultaneously) PK of M1 (Lomitapide Alone) PK of M1 (Coadministered Simultaneously) PK of M3 (Lomitapide Alone) PK of M3 (Coadministered Simultaneously)
Hide Arm/Group Description:
PK of lomitapide following administration of lomitapide alone
PK of lomitapide following administration of lomitapide coadministered with atorvastatin simultaneously
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with atorvastatin simultaneously
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with atorvastatin simultaneously
Overall Number of Participants Analyzed 16 16 16 16 14 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
40.4
(40.8%)
76.7
(45.1%)
79.1
(34.7%)
78.7
(36.3%)
469
(68.6%)
487
(544%)
5.Primary Outcome
Title t1/2
Hide Description Apparent terminal elimination half-life of lomitapide and its 2 primary metabolites (M1 & M3), following administration of lomitapide alone and coadministered with atorvastatin simultaneously (Arm 1)
Time Frame Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. 2 subjects were removed from formal statistical analysis of "PK of M3 (Lomitapide alone)" due to missing value of AUC0-∞ for Analyte M3.
Arm/Group Title PK of Lomitapide (Lomitapide Alone) PK of Lomitapide (Coadministered Simultaneously) PK of M1 (Lomitapide Alone) PK of M1 (Coadministered Simultaneously) PK of M3 (Lomitapide Alone) PK of M3 (Coadministered Simultaneously)
Hide Arm/Group Description:
PK of lomitapide following administration of lomitapide alone
PK of lomitapide following administration of lomitapide coadministered with atorvastatin simultaneously
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with atorvastatin simultaneously
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with atorvastatin simultaneously
Overall Number of Participants Analyzed 16 16 16 16 14 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr
50.7
(22.1%)
50.4
(21.8%)
34.0
(17.7%)
35.2
(16.2%)
50.2
(25.6%)
43.2
(18.4%)
6.Secondary Outcome
Title Cmax
Hide Description Maximum observed plasma concentration of lomitapide and its 2 primary metabolites (M1 & M3) following administration of lomitapide alone and coadministered with atorvastatin 12 hours apart (Arm 2)
Time Frame Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. 1 subject was removed from formal statistical analysis due to all BLQ values on Day 1 for lomitapide, M1 and M3.
Arm/Group Title PK of Lomitapide (Lomitapide Alone) PK of Lomitapide (Coadministered 12 Hours Apart) PK of M1 (Lomitapide Alone) PK of M1 (Coadministered 12 Hours Apart) PK of M3 (Lomitapide Alone) PK of M3 (Coadministered 12 Hours Apart)
Hide Arm/Group Description:
PK of lomitapide following administration of lomitapide alone
PK of lomitapide following administration of lomitapide coadministered with atorvastatin 12 hours apart
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with atorvastatin 12 hours apart
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with atorvastatin 12 hours apart
Overall Number of Participants Analyzed 15 16 15 16 15 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1.09
(49.8%)
1.39
(40.0%)
2.38
(25.5%)
2.66
(25.4%)
28.5
(29.9%)
35.9
(27.3%)
7.Secondary Outcome
Title Tmax
Hide Description Time to reach maximum observed plasma concentration of lomitapide and its 2 primary metabolites (M1 & M3) following administration of lomitapide alone and coadministered with atorvastatin 12 hours apart (Arm 2)
Time Frame Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. 1 subject was removed from formal statistical analysis due to all BLQ values on Day 1 for lomitapide, M1 and M3.
Arm/Group Title PK of Lomitapide (Lomitapide Alone) PK of Lomitapide (Coadministered 12 Hours Apart) PK of M1 (Lomitapide Alone) PK of M1 (Coadministered 12 Hours Apart) PK of M3 (Lomitapide Alone) PK of M3 (Coadministered 12 Hours Apart)
Hide Arm/Group Description:
PK of lomitapide following administration of lomitapide alone
PK of lomitapide following administration of lomitapide coadministered with atorvastatin 12 hours apart
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with atorvastatin 12 hours apart
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with atorvastatin 12 hours apart
Overall Number of Participants Analyzed 15 16 15 16 15 16
Median (Full Range)
Unit of Measure: hr
8.02
(4.00 to 12.0)
8.00
(5.00 to 11.8)
8.00
(4.00 to 12.0)
8.00
(5.07 to 11.8)
6.00
(3.00 to 10.0)
5.00
(3.00 to 8.00)
8.Secondary Outcome
Title AUC0-t
Hide Description Area under the concentration-time curve from zero to the last quantifiable concentration of lomitapide and its 2 primary metabolites (M1 & M3) following administration of lomitapide alone and coadministered with atorvastatin 12 hours apart (Arm 2)
Time Frame Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. 1 subject was removed from formal statistical analysis due to all BLQ values on Day 1 for lomitapide, M1 and M3.
Arm/Group Title PK of Lomitapide (Lomitapide Alone) PK of Lomitapide (Coadministered 12 Hours Apart) PK of M1 (Lomitapide Alone) PK of M1 (Coadministered 12 Hours Apart) PK of M3 (Lomitapide Alone) PK of M3 (Coadministered 12 Hours Apart)
Hide Arm/Group Description:
PK of lomitapide following administration of lomitapide alone
PK of lomitapide following administration of lomitapide coadministered with atorvastatin 12 hours apart
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with atorvastatin 12 hours apart
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with atorvastatin 12 hours apart
Overall Number of Participants Analyzed 15 16 15 16 15 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
38.8
(40.8%)
50.5
(26.0%)
68.3
(33.0%)
77.6
(27.9%)
410
(32.6%)
542
(31.2%)
9.Secondary Outcome
Title AUC0-∞
Hide Description Area under the concentration-time curve from zero to infinity of lomitapide and its 2 primary metabolites (M1 & M3) following administration of lomitapide alone and coadministered with atorvastatin 12 hours apart (Arm 2)
Time Frame Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. 3 subjects were removed from formal statistical analysis due to BLQ values on Day 1, missing value of AUC0-∞ on Day 1, and missing value of AUC0-∞ on Day 15.
Arm/Group Title PK of Lomitapide (Lomitapide Alone) PK of Lomitapide (Coadminister 12 Hours Apart) PK of M1 (Lomitapide Alone) PK of M1 (Coadministered 12 Hours Apart) PK of M3 (Lomitapide Alone) PK of M3 (Coadministered 12 Hours Apart)
Hide Arm/Group Description:
PK of lomitapide following administration of lomitapide alone
PK of lomitapide following administration of lomitapide coadministered with atorvastatin 12 hours apart
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with atorvastatin 12 hours apart
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with atorvastatin 12 hours apart
Overall Number of Participants Analyzed 15 16 15 16 14 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
42.8
(39.6%)
55.8
(25.2%)
70.0
(32.8%)
79.2
(27.8%)
406
(30.8%)
553
(32.4%)
10.Secondary Outcome
Title t1/2
Hide Description Apparent terminal elimination half-life of lomitapide and its 2 primary metabolites (M1 & M3) following administration of lomitapide alone and coadministered with atorvastatin 12 hours apart (Arm 2)
Time Frame Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. 3 subjects were removed from formal statistical analysis due to BLQ values on Day 1, missing value of AUC0-∞ on Day 1, and missing value of AUC0-∞ on Day 15.
Arm/Group Title PK of Lomitapide (Lomitapide Alone) PK of Lomitapide (Coadministered 12 Hours Apart) PK of M1 (Lomitapide Alone) PK of M1 (Coadministered 12 Hours Apart) PK of M3 (Lomitapide Alone) PK of M3 (Coadministered 12 Hours Apart)
Hide Arm/Group Description:
PK of lomitapide following administration of lomitapide alone
PK of lomitapide following administration of lomitapide coadministered with atorvastatin 12 hours apart
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with atorvastatin 12 hours apart
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with atorvastatin 12 hours apart
Overall Number of Participants Analyzed 15 16 15 16 14 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr
52.0
(19.5%)
54.7
(28.5%)
31.2
(24.0%)
32.3
(18.2%)
48.0
(33.4%)
49.7
(21.9%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lomitapide & Atorvastatin - Taken Together Lomitapide & Atorvastatin - Approx. 12 Hours Between
Hide Arm/Group Description

2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 & Day 15)

11 single oral doses of atorvastatin (80 mg) (Day 11 through day 21)

lomitapide: 20 mg dose

Atorvastatin: 80 mg

2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 & Day 15)

11 single oral doses of atorvastatin (80 mg) (Day 12 through day 22)

lomitapide: 20 mg dose

Atorvastatin: 80 mg

All-Cause Mortality
Lomitapide & Atorvastatin - Taken Together Lomitapide & Atorvastatin - Approx. 12 Hours Between
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/16 (0.00%)    
Hide Serious Adverse Events
Lomitapide & Atorvastatin - Taken Together Lomitapide & Atorvastatin - Approx. 12 Hours Between
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/16 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lomitapide & Atorvastatin - Taken Together Lomitapide & Atorvastatin - Approx. 12 Hours Between
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/16 (75.00%)      5/16 (31.25%)    
Gastrointestinal disorders     
Diarrhoea  1  10/16 (62.50%)  11 2/16 (12.50%)  3
Abdominal Pain  1  4/16 (25.00%)  5 1/16 (6.25%)  1
Nausea  1  3/16 (18.75%)  3 0/16 (0.00%)  0
Constipation  1  0/16 (0.00%)  0 1/16 (6.25%)  1
Toothache  1  1/16 (6.25%)  1 0/16 (0.00%)  0
Lip Dry  1  0/16 (0.00%)  0 2/16 (12.50%)  2
Metabolism and nutrition disorders     
Decreased Appitite  1  3/16 (18.75%)  3 0/16 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Neck Pain  1  1/16 (6.25%)  1 0/16 (0.00%)  0
Nervous system disorders     
Headache  1  2/16 (12.50%)  2 0/16 (0.00%)  0
Dizziness  1  1/16 (6.25%)  1 0/16 (0.00%)  0
Reproductive system and breast disorders     
Dysmenorrhoea  1  1/16 (6.25%)  1 0/16 (0.00%)  0
Skin and subcutaneous tissue disorders     
Blister  1  0/16 (0.00%)  0 2/16 (12.50%)  2
Dry Skin  1  1/16 (6.25%)  1 0/16 (0.00%)  0
Skin Irritation  1  1/16 (6.25%)  1 0/16 (0.00%)  0
Vascular disorders     
Flushing  1  1/16 (6.25%)  1 0/16 (0.00%)  0
1
Term from vocabulary, MedDRA 16.1
Indicates events were collected by 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.
Described in site contract.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alison Long, MD - VP Clinical
Organization: Aegerion Pharmaceuticals, Inc.
Phone: 617-242-5142
EMail: alison.long@aegerion.com
Layout table for additonal information
Responsible Party: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02080455    
Other Study ID Numbers: AEGR-733-024
First Submitted: March 5, 2014
First Posted: March 6, 2014
Results First Submitted: June 23, 2015
Results First Posted: March 10, 2020
Last Update Posted: March 10, 2020