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Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects

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ClinicalTrials.gov Identifier: NCT02080468
Recruitment Status : Completed
First Posted : March 6, 2014
Results First Posted : March 11, 2019
Last Update Posted : March 11, 2019
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 Healthy
Interventions Drug: lomitapide
Drug: EE/norgestimate
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lomitapide & EE/Norgestimate - Taken Together Lomitapide & EE/Norgestimate - Taken 12 Hours Apart
Hide Arm/Group Description

2 single oral doses of lomitapide (20 mg) (Day 1 & Day 22)

21 single oral doses of EE/Norgestimate(Day 8 through day 28)

lomitapide: 20 mg

EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet

2 single oral doses of lomitapide (20 mg) (Day 1 & Day 22)

21 single oral doses of EE/Norgestimate(Day 9 through day 29)

lomitapide: 20 mg

EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet

Period Title: Overall Study
Started 16 16
Completed 14 14
Not Completed 2 2
Arm/Group Title Lomitapide & EE/Norgestimate - Taken Together Lomitapide & EE/Norgestimate - Taken 12 Hours Apart Total
Hide Arm/Group Description

2 single oral doses of lomitapide (20 mg) (Day 1 & Day 22)

21 single oral doses of EE/Norgestimate(Day 8 through day 28)

lomitapide: 20 mg

EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet

2 single oral doses of lomitapide (20 mg) (Day 1 & Day 22)

21 single oral doses of EE/Norgestimate(Day 9 through day 29)

lomitapide: 20 mg

EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet

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
30  (6.4) 29  (5.7) 29  (6.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Female
16
 100.0%
16
 100.0%
32
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Hispanic or Latino
6
  37.5%
3
  18.8%
9
  28.1%
Not Hispanic or Latino
10
  62.5%
13
  81.3%
23
  71.9%
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%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  56.3%
10
  62.5%
19
  59.4%
White
7
  43.8%
5
  31.3%
12
  37.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   6.3%
1
   3.1%
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 for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Hide Description Maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 & M3
Time Frame 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.
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 EE/Norgestimate simultaneously
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
Overall Number of Participants Analyzed 16 14 16 14 16 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1.03
(39.1%)
1.39
(58.4%)
2.96
(27.0%)
2.95
(19.4%)
36.3
(32.1%)
34.0
(27.9%)
2.Primary Outcome
Title Tmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Hide Description Time to reach maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 & M3.
Time Frame 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.
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 EE/Norgestimate simultaneously
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
Overall Number of Participants Analyzed 16 14 16 14 16 14
Median (Full Range)
Unit of Measure: hr
6.00
(4.00 to 12.0)
5.00
(1.00 to 18.0)
8.28
(5.00 to 12.0)
6.00
(2.00 to 12.0)
5.02
(3.00 to 12.0)
3.97
(1.00 to 6.00)
3.Primary Outcome
Title AUC0-t for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Hide Description Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its 2 primary metabolites, M1 & M3.
Time Frame 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.
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 EE/Norgestimate simultaneously
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
Overall Number of Participants Analyzed 16 14 16 14 16 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
33.5
(35.0%)
42.7
(49.5%)
89.3
(35.6%)
96.8
(32.1%)
456
(41.2%)
371
(36.1%)
4.Primary Outcome
Title AUC0-∞ for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Hide Description Area under the concentration-time curve from zero to infinity of lomitapide and its 2 primary metabolites, M1 & M3.
Time Frame 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.
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 EE/Norgestimate simultaneously
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
Overall Number of Participants Analyzed 16 14 16 14 16 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
36.5
(34.8%)
46.5
(49.1%)
91.4
(35.8%)
99.4
(32.4%)
463
(40.9%)
377
(36.0%)
5.Primary Outcome
Title t1/2 for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Hide Description Apparent terminal elimination half-life of lomitapide and its 2 primary metabolites, M1 & M3.
Time Frame 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.
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 EE/Norgestimate simultaneously
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
Overall Number of Participants Analyzed 16 14 16 14 16 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr
51.0
(16.1%)
53.6
(19.0%)
32.5
(20.3%)
36.8
(30.3%)
38.3
(32.7%)
39.8
(26.2%)
6.Secondary Outcome
Title Cmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Hide Description Maximum observed plasma concentration of lomitapide and its metabolites, M1 & M3.
Time Frame 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.
Arm/Group Title PK of Lomitapide (Lomitapide Alone) PK of Lomitapide (Codministered 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 EE/Norgestimate 12 hours apart
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart
Overall Number of Participants Analyzed 16 14 16 14 16 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1.05
(50.7%)
1.39
(56.5%)
2.87
(20.6%)
3.04
(22.8%)
37.8
(26.2%)
33.0
(28.0%)
7.Secondary Outcome
Title Tmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Hide Description Time to reach maximum observed plasma concentration of lomitapide and its metabolites, M1 & M3.
Time Frame 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.
Arm/Group Title PK of Lomitapide (Lomitapide Alone) PK of Lomitapide (Codministered 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 EE/Norgestimate 12 hours apart
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart
Overall Number of Participants Analyzed 16 14 16 14 16 14
Mean (Full Range)
Unit of Measure: hr
8.00
(5.00 to 10.0)
8.00
(3.00 to 11.8)
9.07
(5.00 to 12.0)
8.00
(3.00 to 11.9)
6.00
(5.00 to 10.0)
5.50
(2.00 to 8.40)
8.Secondary Outcome
Title AUC0-t for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Hide Description Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its metabolites, M1 & M3.
Time Frame 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.
Arm/Group Title PK of Lomitapide (Lomitapide Alone) PK of Lomitapide (Codministered 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 EE/Norgestimate 12 hours apart
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart
Overall Number of Participants Analyzed 16 14 16 14 16 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
37.6
(49.9%)
46.5
(55.1%)
92.3
(31.1%)
93.7
(34.2%)
520
(30.1%)
377
(31.9%)
9.Secondary Outcome
Title AUC0-∞ for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Hide Description Area under the concentration-time curve from zero to infinity of lomitapide and its metabolites, M1 & M3.
Time Frame 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.
Arm/Group Title PK of Lomitapide (Lomitapide Alone) PK of Lomitapide (Codministered 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 EE/Norgestimate 12 hours apart
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart
Overall Number of Participants Analyzed 16 14 16 14 16 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
41.1
(50.9%)
51.2
(55.3%)
94.5
(31.3%)
96.4
(34.6%)
528
(30.0%)
383
(31.7%)
10.Secondary Outcome
Title t1/2 for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Hide Description Apparent terminal elimination half-life of lomitapide and its metabolites, M1 & M3.
Time Frame 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.
Arm/Group Title PK of Lomitapide (Lomitapide Alone) PK of Lomitapide (Codministered 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 EE/Norgestimate 12 hours apart
PK of M1 following administration of lomitapide alone
PK of M1 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart
PK of M3 following administration of lomitapide alone
PK of M3 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart
Overall Number of Participants Analyzed 16 14 16 14 16 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr
51.0
(22.2%)
52.0
(16.1%)
36.2
(21.0%)
37.2
(19.1%)
38.0
(28.0%)
33.6
(23.2%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lomitapide & EE/Norgestimate - Taken Together Lomitapide & EE/Norgestimate - Taken 12 Hours Apart
Hide Arm/Group Description

2 single oral doses of lomitapide (20 mg) (Day 1 & Day 22)

21 single oral doses of EE/Norgestimate(Day 8 through day 28)

lomitapide: 20 mg

EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet

2 single oral doses of lomitapide (20 mg) (Day 1 & Day 22)

21 single oral doses of EE/Norgestimate(Day 9 through day 29)

lomitapide: 20 mg

EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet

All-Cause Mortality
Lomitapide & EE/Norgestimate - Taken Together Lomitapide & EE/Norgestimate - Taken 12 Hours Apart
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/16 (0.00%)    
Hide Serious Adverse Events
Lomitapide & EE/Norgestimate - Taken Together Lomitapide & EE/Norgestimate - Taken 12 Hours Apart
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 & EE/Norgestimate - Taken Together Lomitapide & EE/Norgestimate - Taken 12 Hours Apart
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/16 (50.00%)      7/16 (43.75%)    
Gastrointestinal disorders     
Nausea  1  4/16 (25.00%)  5 1/16 (6.25%)  1
Vomitting  1  4/16 (25.00%)  4 1/16 (6.25%)  1
Abdominal pain  1  1/16 (6.25%)  1 0/16 (0.00%)  0
Abdominal pain upper  1  1/16 (6.25%)  1 0/16 (0.00%)  0
Diarrhoea  1  1/16 (6.25%)  1 0/16 (0.00%)  0
General disorders     
Vessel Punction Site Pain  1  2/16 (12.50%)  2 0/16 (0.00%)  0
Infections and infestations     
Fungal infection  1  1/16 (6.25%)  1 0/16 (0.00%)  0
Injury, poisoning and procedural complications     
Procedural dizziness  1  1/16 (6.25%)  1 2/16 (12.50%)  2
Procedural Nausea  1  0/16 (0.00%)  0 2/16 (12.50%)  2
Laceration  1  1/16 (6.25%)  1 0/16 (0.00%)  0
Investigations     
Body temperature increased  1  0/16 (0.00%)  0 1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  1/16 (6.25%)  1 0/16 (0.00%)  0
Nervous system disorders     
Headache  1  2/16 (12.50%)  2 3/16 (18.75%)  3
Presyncope  1  1/16 (6.25%)  1 0/16 (0.00%)  0
Sensory disturbance  1  0/16 (0.00%)  0 1/16 (6.25%)  1
Psychiatric disorders     
Insomnia  1  0/16 (0.00%)  0 1/16 (6.25%)  1
Renal and urinary disorders     
Dysuria  1  1/16 (6.25%)  1 0/16 (0.00%)  0
Reproductive system and breast disorders     
Dysmenorrhoea  1  2/16 (12.50%)  3 0/16 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  0/16 (0.00%)  0 2/16 (12.50%)  2
Nasal congestion  1  0/16 (0.00%)  0 1/16 (6.25%)  2
Pulmonary congestion  1  0/16 (0.00%)  0 1/16 (6.25%)  1
Rhinorrhea  1  0/16 (0.00%)  0 1/16 (6.25%)  1
Sneezing  1  0/16 (0.00%)  0 1/16 (6.25%)  1
Skin and subcutaneous tissue disorders     
Rash  1  0/16 (0.00%)  0 1/16 (6.25%)  2
hyperhidrosis  1  0/16 (0.00%)  0 1/16 (6.25%)  1
Vascular disorders     
Hot flush  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: 617-500-5142
EMail: alison.long@aegerion.com
Layout table for additonal information
Responsible Party: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02080468    
Other Study ID Numbers: AEGR-733-029
First Submitted: March 5, 2014
First Posted: March 6, 2014
Results First Submitted: June 23, 2015
Results First Posted: March 11, 2019
Last Update Posted: March 11, 2019