Trial Outcomes & Findings for Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia (NCT NCT00690443)
NCT ID: NCT00690443
Last Updated: 2018-02-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Baseline and 8 weeks of treatment
Results posted on
2018-02-23
Participant Flow
This study was performed from 12 May 2008 to 29 Aug 2008. A total of 5 medical clinics participated in the study.
5-week run-in period during which patients were to follow a low-fat diet and washout from previous lipid lowering therapies.
Participant milestones
| Measure |
Atorvastatin 20 mg
Oral atorvastatin 20 mg for 8 weeks
|
Atorvastatin 20 mg + Lomitapide
Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
|
Overall Study
COMPLETED
|
22
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Atorvastatin 20 mg
Oral atorvastatin 20 mg for 8 weeks
|
Atorvastatin 20 mg + Lomitapide
Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
Baseline Characteristics
Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia
Baseline characteristics by cohort
| Measure |
Atorvastatin 20 mg
n=23 Participants
Oral atorvastatin 20 mg for 8 weeks
|
Atorvastatin 20 mg + Lomitapide
n=21 Participants
Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.8 Years
STANDARD_DEVIATION 6.22 • n=99 Participants
|
57.8 Years
STANDARD_DEVIATION 8.06 • n=107 Participants
|
58.3 Years
STANDARD_DEVIATION 7.09 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeks of treatmentOutcome measures
| Measure |
Atorvastatin 20 mg
n=22 Participants
Oral atorvastatin 20 mg for 8 weeks
|
Atorvastatin 20 mg + Lomitapide
n=19 Participants
Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
|
|---|---|---|
|
Percent Change in LDL-C After 8 Weeks of Therapy
|
-39.6 Percent Change
Standard Deviation 14.35
|
-49.9 Percent Change
Standard Deviation 26.78
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksOutcome measures
| Measure |
Atorvastatin 20 mg
n=23 Participants
Oral atorvastatin 20 mg for 8 weeks
|
Atorvastatin 20 mg + Lomitapide
n=19 Participants
Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
|
|---|---|---|
|
Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.
Change in non-HDL-C
|
-39.6 Percent
Standard Deviation 10.78
|
-45.8 Percent
Standard Deviation 17.68
|
|
Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.
Change in Apo B
|
-33.6 Percent
Standard Deviation 10.19
|
-37.7 Percent
Standard Deviation 17.05
|
|
Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.
Change in Apo A-1
|
4.8 Percent
Standard Deviation 7.53
|
-7.8 Percent
Standard Deviation 8.85
|
|
Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.
Change in hs-CRP
|
-12.0 Percent
Standard Deviation 43.21
|
60.5 Percent
Standard Deviation 187.50
|
|
Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.
Change in body weight
|
0.0 Percent
Standard Deviation 1.38
|
-0.7 Percent
Standard Deviation 1.49
|
|
Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.
Change in LDL-C
|
-42.5 Percent
Standard Deviation 12.70
|
-51.0 Percent
Standard Deviation 18.34
|
|
Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.
Change in TC
|
-31.3 Percent
Standard Deviation 9.23
|
-38.1 Percent
Standard Deviation 15.38
|
|
Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.
Change in TGs
|
-21.5 Percent
Standard Deviation 18.31
|
-17.8 Percent
Standard Deviation 28.32
|
|
Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.
Change in HDL-C
|
6.7 Percent
Standard Deviation 8.07
|
-1.9 Percent
Standard Deviation 10.73
|
Adverse Events
Atorvastatin 20 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Atorvastatin 20 mg + Lomitapide
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atorvastatin 20 mg
n=23 participants at risk
Oral atorvastatin 20 mg for 8 weeks
|
Atorvastatin 20 mg + Lomitapide
n=21 participants at risk
Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
13.0%
3/23 • Number of events 3
|
47.6%
10/21 • Number of events 10
|
|
Gastrointestinal disorders
Flatuence
|
8.7%
2/23 • Number of events 2
|
19.0%
4/21 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
8.7%
2/23 • Number of events 2
|
14.3%
3/21 • Number of events 3
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Number of events 2
|
14.3%
3/21 • Number of events 3
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/23
|
19.0%
4/21 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal distension
|
13.0%
3/23 • Number of events 3
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/23
|
14.3%
3/21 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23
|
14.3%
3/21 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
8.7%
2/23 • Number of events 2
|
4.8%
1/21 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/23
|
9.5%
2/21 • Number of events 2
|
|
Injury, poisoning and procedural complications
Foot fracture
|
8.7%
2/23 • Number of events 2
|
0.00%
0/21
|
Additional Information
Chief Medical Officer
Aegerion Pharmaceuticals
Phone: 617-500-7867
Results disclosure agreements
- Principal investigator is a sponsor employee Information is unavailable.
- Publication restrictions are in place
Restriction type: OTHER