Trial Outcomes & Findings for Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects. (NCT NCT02080455)

NCT ID: NCT02080455

Last Updated: 2020-03-10

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing

Results posted on

2020-03-10

Participant Flow

Participant milestones

Participant milestones
Measure	Lomitapide & Atorvastatin - Taken Together 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	Lomitapide & Atorvastatin - Approx. 12 Hours Between 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
Overall Study STARTED	16	16
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lomitapide & Atorvastatin - Taken Together n=16 Participants 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	Lomitapide & Atorvastatin - Approx. 12 Hours Between n=16 Participants 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 n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=93 Participants	16 Participants n=4 Participants	32 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	41 years STANDARD_DEVIATION 9.1 • n=93 Participants	39 years STANDARD_DEVIATION 9.5 • n=4 Participants	40 years STANDARD_DEVIATION 9.2 • n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	8 Participants n=4 Participants	16 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	8 Participants n=4 Participants	16 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	12 Participants n=4 Participants	13 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=93 Participants	4 Participants n=4 Participants	19 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	8 Participants n=93 Participants	2 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) White	8 Participants n=93 Participants	13 Participants n=4 Participants	21 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	16 participants n=93 Participants	16 participants n=4 Participants	32 participants n=27 Participants

PRIMARY outcome

Timeframe: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing

Population: The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data.

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)

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=16 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=16 Participants PK of lomitapide following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M1 (Lomitapide Alone) n=16 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=16 Participants PK of M1 following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M3 (Lomitapide Alone) n=16 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=16 Participants PK of M3 following administration of lomitapide coadministered with atorvastatin simultaneously
Cmax	0.940 ng/mL Geometric Coefficient of Variation 34.5	2.00 ng/mL Geometric Coefficient of Variation 52.9	2.24 ng/mL Geometric Coefficient of Variation 22.8	2.11 ng/mL Geometric Coefficient of Variation 31.9	32.3 ng/mL Geometric Coefficient of Variation 40.6	27.2 ng/mL Geometric Coefficient of Variation 62.0

PRIMARY outcome

Timeframe: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing

Population: The PK Population consisted of all subjects who received at least one dose of study drug and had evaluable PK data.

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)

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=16 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=16 Participants PK of lomitapide following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M1 (Lomitapide Alone) n=16 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=16 Participants PK of M1 following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M3 (Lomitapide Alone) n=16 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=16 Participants PK of M3 following administration of lomitapide coadministered with atorvastatin simultaneously
Tmax	6.00 hr Interval 3.0 to 10.0	10.0 hr Interval 3.0 to 23.8	6.02 hr Interval 4.0 to 10.0	10.0 hr Interval 4.0 to 23.8	4.00 hr Interval 3.0 to 12.0	6.00 hr Interval 3.0 to 23.8

PRIMARY outcome

Timeframe: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing

Population: The PK Population consisted of all subjects who received at least one dose of study drug and had evaluable PK data.

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)

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=16 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=16 Participants PK of lomitapide following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M1 (Lomitapide Alone) n=16 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=16 Participants PK of M1 following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M3 (Lomitapide Alone) n=16 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=16 Participants PK of M3 following administration of lomitapide coadministered with atorvastatin simultaneously
AUC0-t	36.4 ng*hr/mL Geometric Coefficient of Variation 38.4	71.5 ng*hr/mL Geometric Coefficient of Variation 45.3	76.8 ng*hr/mL Geometric Coefficient of Variation 34.4	76.3 ng*hr/mL Geometric Coefficient of Variation 36.0	434 ng*hr/mL Geometric Coefficient of Variation 65.5	475 ng*hr/mL Geometric Coefficient of Variation 55.0

PRIMARY outcome

Timeframe: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing

Population: 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.

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)

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=16 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=16 Participants PK of lomitapide following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M1 (Lomitapide Alone) n=16 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=16 Participants PK of M1 following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M3 (Lomitapide Alone) n=14 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=16 Participants PK of M3 following administration of lomitapide coadministered with atorvastatin simultaneously
AUC0-∞	40.4 ng*hr/mL Geometric Coefficient of Variation 40.8	76.7 ng*hr/mL Geometric Coefficient of Variation 45.1	79.1 ng*hr/mL Geometric Coefficient of Variation 34.7	78.7 ng*hr/mL Geometric Coefficient of Variation 36.3	469 ng*hr/mL Geometric Coefficient of Variation 68.6	487 ng*hr/mL Geometric Coefficient of Variation 544

PRIMARY outcome

Timeframe: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing

Population: 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.

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)

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=16 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=16 Participants PK of lomitapide following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M1 (Lomitapide Alone) n=16 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=16 Participants PK of M1 following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M3 (Lomitapide Alone) n=14 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=16 Participants PK of M3 following administration of lomitapide coadministered with atorvastatin simultaneously
t1/2	50.7 hr Geometric Coefficient of Variation 22.1	50.4 hr Geometric Coefficient of Variation 21.8	34.0 hr Geometric Coefficient of Variation 17.7	35.2 hr Geometric Coefficient of Variation 16.2	50.2 hr Geometric Coefficient of Variation 25.6	43.2 hr Geometric Coefficient of Variation 18.4

SECONDARY outcome

Timeframe: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing

Population: 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.

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)

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=15 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=16 Participants PK of lomitapide following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M1 (Lomitapide Alone) n=15 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=16 Participants PK of M1 following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M3 (Lomitapide Alone) n=15 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=16 Participants PK of M3 following administration of lomitapide coadministered with atorvastatin simultaneously
Cmax	1.09 ng/mL Geometric Coefficient of Variation 49.8	1.39 ng/mL Geometric Coefficient of Variation 40.0	2.38 ng/mL Geometric Coefficient of Variation 25.5	2.66 ng/mL Geometric Coefficient of Variation 25.4	28.5 ng/mL Geometric Coefficient of Variation 29.9	35.9 ng/mL Geometric Coefficient of Variation 27.3

SECONDARY outcome

Timeframe: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing

Population: 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.

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)

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=15 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=16 Participants PK of lomitapide following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M1 (Lomitapide Alone) n=15 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=16 Participants PK of M1 following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M3 (Lomitapide Alone) n=15 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=16 Participants PK of M3 following administration of lomitapide coadministered with atorvastatin simultaneously
Tmax	8.02 hr Interval 4.0 to 12.0	8.00 hr Interval 5.0 to 11.8	8.00 hr Interval 4.0 to 12.0	8.00 hr Interval 5.07 to 11.8	6.00 hr Interval 3.0 to 10.0	5.00 hr Interval 3.0 to 8.0

SECONDARY outcome

Timeframe: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing

Population: 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.

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)

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=15 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=16 Participants PK of lomitapide following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M1 (Lomitapide Alone) n=15 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=16 Participants PK of M1 following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M3 (Lomitapide Alone) n=15 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=16 Participants PK of M3 following administration of lomitapide coadministered with atorvastatin simultaneously
AUC0-t	38.8 ng*hr/mL Geometric Coefficient of Variation 40.8	50.5 ng*hr/mL Geometric Coefficient of Variation 26.0	68.3 ng*hr/mL Geometric Coefficient of Variation 33.0	77.6 ng*hr/mL Geometric Coefficient of Variation 27.9	410 ng*hr/mL Geometric Coefficient of Variation 32.6	542 ng*hr/mL Geometric Coefficient of Variation 31.2

SECONDARY outcome

Timeframe: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing

Population: 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.

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)

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=15 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=16 Participants PK of lomitapide following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M1 (Lomitapide Alone) n=15 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=16 Participants PK of M1 following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M3 (Lomitapide Alone) n=14 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=15 Participants PK of M3 following administration of lomitapide coadministered with atorvastatin simultaneously
AUC0-∞	42.8 ng*hr/mL Geometric Coefficient of Variation 39.6	55.8 ng*hr/mL Geometric Coefficient of Variation 25.2	70.0 ng*hr/mL Geometric Coefficient of Variation 32.8	79.2 ng*hr/mL Geometric Coefficient of Variation 27.8	406 ng*hr/mL Geometric Coefficient of Variation 30.8	553 ng*hr/mL Geometric Coefficient of Variation 32.4

SECONDARY outcome

Timeframe: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing

Population: 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.

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)

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=15 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=16 Participants PK of lomitapide following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M1 (Lomitapide Alone) n=15 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=16 Participants PK of M1 following administration of lomitapide coadministered with atorvastatin simultaneously	PK of M3 (Lomitapide Alone) n=14 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=15 Participants PK of M3 following administration of lomitapide coadministered with atorvastatin simultaneously
t1/2	52.0 hr Geometric Coefficient of Variation 19.5	54.7 hr Geometric Coefficient of Variation 28.5	31.2 hr Geometric Coefficient of Variation 24.0	32.3 hr Geometric Coefficient of Variation 18.2	48.0 hr Geometric Coefficient of Variation 33.4	49.7 hr Geometric Coefficient of Variation 21.9

Adverse Events

Lomitapide & Atorvastatin - Taken Together

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Lomitapide & Atorvastatin - Approx. 12 Hours Between

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lomitapide & Atorvastatin - Taken Together n=16 participants at risk 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	Lomitapide & Atorvastatin - Approx. 12 Hours Between n=16 participants at risk 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
Gastrointestinal disorders Diarrhoea	62.5% 10/16 • Number of events 11	12.5% 2/16 • Number of events 3
Gastrointestinal disorders Abdominal Pain	25.0% 4/16 • Number of events 5	6.2% 1/16 • Number of events 1
Gastrointestinal disorders Nausea	18.8% 3/16 • Number of events 3	0.00% 0/16
Gastrointestinal disorders Constipation	0.00% 0/16	6.2% 1/16 • Number of events 1
Gastrointestinal disorders Toothache	6.2% 1/16 • Number of events 1	0.00% 0/16
Skin and subcutaneous tissue disorders Blister	0.00% 0/16	12.5% 2/16 • Number of events 2
Skin and subcutaneous tissue disorders Dry Skin	6.2% 1/16 • Number of events 1	0.00% 0/16
Skin and subcutaneous tissue disorders Skin Irritation	6.2% 1/16 • Number of events 1	0.00% 0/16
Metabolism and nutrition disorders Decreased Appitite	18.8% 3/16 • Number of events 3	0.00% 0/16
Nervous system disorders Headache	12.5% 2/16 • Number of events 2	0.00% 0/16
Nervous system disorders Dizziness	6.2% 1/16 • Number of events 1	0.00% 0/16
Musculoskeletal and connective tissue disorders Neck Pain	6.2% 1/16 • Number of events 1	0.00% 0/16
Reproductive system and breast disorders Dysmenorrhoea	6.2% 1/16 • Number of events 1	0.00% 0/16
Vascular disorders Flushing	6.2% 1/16 • Number of events 1	0.00% 0/16
Gastrointestinal disorders Lip Dry	0.00% 0/16	12.5% 2/16 • Number of events 2

Additional Information

Alison Long, MD - VP Clinical

Aegerion Pharmaceuticals, Inc.

Phone: 617-242-5142

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Described in site contract.
Publication restrictions are in place

Restriction type: OTHER