Trial Outcomes & Findings for AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia (NCT NCT00474240)
NCT ID: NCT00474240
Last Updated: 2018-03-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
157 participants
Primary outcome timeframe
Atfer 8 weeks on study drug
Results posted on
2018-03-20
Participant Flow
The study was performed from 05 November 2007 to 04 August 2008 at 17 medical clinics within the United States.
Subjects who were previously on a lipid lowering therapy underwent a 5-week washout period. All subjects were on a low-fat diet (\<30% calories from fat) starting 5 weeks prior to study drug treatment and continuing for the duration of the study.
Participant milestones
| Measure |
Placebo
Placebo capsule taken orally once daily
|
Atorvastatin 20 mg
Atorvastatin 20 mg taken orally once daily
|
AEGR-733 5 mg
AEGR-733 5 mg taken orally once daily
|
AEGR-733 10 mg
AEGR-733 10 mg taken orally once daily
|
AEGR-733 5 mg + Atorvastatin 20 mg
One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
|
AEGR-733 10 mg + Atorvastatin 20 mg
One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
26
|
26
|
26
|
26
|
|
Overall Study
COMPLETED
|
26
|
25
|
17
|
10
|
18
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
9
|
16
|
8
|
18
|
Reasons for withdrawal
| Measure |
Placebo
Placebo capsule taken orally once daily
|
Atorvastatin 20 mg
Atorvastatin 20 mg taken orally once daily
|
AEGR-733 5 mg
AEGR-733 5 mg taken orally once daily
|
AEGR-733 10 mg
AEGR-733 10 mg taken orally once daily
|
AEGR-733 5 mg + Atorvastatin 20 mg
One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
|
AEGR-733 10 mg + Atorvastatin 20 mg
One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
2
|
3
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
9
|
14
|
5
|
16
|
|
Overall Study
Removed due to lab value
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia
Baseline characteristics by cohort
| Measure |
Placebo
n=27 Participants
Placebo capsule taken orally once daily
|
Atorvastatin 20 mg
n=26 Participants
Atorvastatin 20 mg taken orally once daily
|
AEGR-733 5 mg
n=26 Participants
AEGR-733 5 mg taken orally once daily
|
AEGR-733 10 mg
n=26 Participants
AEGR-733 10 mg taken orally once daily
|
AEGR-733 5 mg + Atorvastatin 20 mg
n=26 Participants
One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
|
AEGR-733 10 mg + Atorvastatin 20 mg
n=26 Participants
One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53 Years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
56 Years
STANDARD_DEVIATION 8.4 • n=107 Participants
|
56 Years
STANDARD_DEVIATION 8.3 • n=206 Participants
|
54 Years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
51 Years
STANDARD_DEVIATION 10.1 • n=31 Participants
|
53 Years
STANDARD_DEVIATION 9.7 • n=30 Participants
|
54 Years
STANDARD_DEVIATION 10 • n=3 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
16 Participants
n=30 Participants
|
87 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
70 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
26 Participants
n=30 Participants
|
150 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 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
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
23 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
22 Participants
n=30 Participants
|
127 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=99 Participants
|
26 participants
n=107 Participants
|
26 participants
n=206 Participants
|
26 participants
n=7 Participants
|
26 participants
n=31 Participants
|
26 participants
n=30 Participants
|
157 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Atfer 8 weeks on study drugPopulation: Intent To Treat
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo capsule taken orally once daily
|
Atorvastatin 20 mg
n=24 Participants
Atorvastatin 20 mg taken orally once daily
|
AEGR-733 5 mg
n=18 Participants
AEGR-733 5 mg taken orally once daily
|
AEGR-733 10 mg
n=10 Participants
AEGR-733 10 mg taken orally once daily
|
AEGR-733 5 mg + Atorvastatin 20 mg
n=18 Participants
One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
|
AEGR-733 10 mg + Atorvastatin 20 mg
n=9 Participants
One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in LDL-C at 8 Weeks
|
2 Percent Change
Standard Deviation 11.2
|
-42 Percent Change
Standard Deviation 16.4
|
-16 Percent Change
Standard Deviation 17.3
|
-37 Percent Change
Standard Deviation 23.0
|
-47 Percent Change
Standard Deviation 19.2
|
-50 Percent Change
Standard Deviation 28.0
|
SECONDARY outcome
Timeframe: After 8 weeks of study drugPopulation: Intent To Treat
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo capsule taken orally once daily
|
Atorvastatin 20 mg
n=25 Participants
Atorvastatin 20 mg taken orally once daily
|
AEGR-733 5 mg
n=19 Participants
AEGR-733 5 mg taken orally once daily
|
AEGR-733 10 mg
n=10 Participants
AEGR-733 10 mg taken orally once daily
|
AEGR-733 5 mg + Atorvastatin 20 mg
n=18 Participants
One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
|
AEGR-733 10 mg + Atorvastatin 20 mg
n=9 Participants
One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline of Other Lipids
Percent change from baseline in total cholesterol
|
2 Percent
Standard Deviation 9.9
|
-30 Percent
Standard Deviation 12.4
|
-18 Percent
Standard Deviation 14.6
|
-33 Percent
Standard Deviation 19.0
|
-37 Percent
Standard Deviation 15.3
|
-40 Percent
Standard Deviation 20.7
|
|
Percent Change From Baseline of Other Lipids
Percent change from baseline in total Apo B
|
0 Percent
Standard Deviation 11.0
|
-34 Percent
Standard Deviation 13.0
|
-17 Percent
Standard Deviation 12.4
|
-36 Percent
Standard Deviation 21.9
|
-41 Percent
Standard Deviation 16.9
|
-46 Percent
Standard Deviation 19.8
|
|
Percent Change From Baseline of Other Lipids
Percent change from baseline in non-HDL-C
|
2 Percent
Standard Deviation 10.3
|
-38 Percent
Standard Deviation 15.8
|
-19 Percent
Standard Deviation 17.1
|
-36 Percent
Standard Deviation 26.0
|
-45 Percent
Standard Deviation 17.7
|
-48 Percent
Standard Deviation 24.5
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Atorvastatin 20 mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
AEGR-733 5 mg
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
AEGR-733 10 mg
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
AEGR-733 5 mg + Atorvastatin 20 mg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
AEGR-733 10 mg + Atorvastatin 20 mg
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=27 participants at risk
Placebo capsule taken orally once daily
|
Atorvastatin 20 mg
n=26 participants at risk
Atorvastatin 20 mg taken orally once daily
|
AEGR-733 5 mg
n=26 participants at risk
AEGR-733 5 mg taken orally once daily
|
AEGR-733 10 mg
n=26 participants at risk
AEGR-733 10 mg taken orally once daily
|
AEGR-733 5 mg + Atorvastatin 20 mg
n=26 participants at risk
One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
|
AEGR-733 10 mg + Atorvastatin 20 mg
n=26 participants at risk
One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/27
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
Other adverse events
| Measure |
Placebo
n=27 participants at risk
Placebo capsule taken orally once daily
|
Atorvastatin 20 mg
n=26 participants at risk
Atorvastatin 20 mg taken orally once daily
|
AEGR-733 5 mg
n=26 participants at risk
AEGR-733 5 mg taken orally once daily
|
AEGR-733 10 mg
n=26 participants at risk
AEGR-733 10 mg taken orally once daily
|
AEGR-733 5 mg + Atorvastatin 20 mg
n=26 participants at risk
One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
|
AEGR-733 10 mg + Atorvastatin 20 mg
n=26 participants at risk
One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
2/27 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
61.5%
16/26 • Number of events 16
|
57.7%
15/26 • Number of events 15
|
42.3%
11/26 • Number of events 11
|
76.9%
20/26 • Number of events 20
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
19.2%
5/26 • Number of events 5
|
26.9%
7/26 • Number of events 7
|
19.2%
5/26 • Number of events 5
|
53.8%
14/26 • Number of events 14
|
|
Gastrointestinal disorders
Flatulence
|
7.4%
2/27 • Number of events 2
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
15.4%
4/26 • Number of events 4
|
15.4%
4/26 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal Distension
|
3.7%
1/27 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
15.4%
4/26 • Number of events 4
|
|
Gastrointestinal disorders
Nasopharyngitis
|
11.1%
3/27 • Number of events 3
|
7.7%
2/26 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
15.4%
4/26 • Number of events 4
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
7.4%
2/27 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
11.5%
3/26 • Number of events 3
|
11.5%
3/26 • Number of events 3
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
3.7%
1/27 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
11.5%
3/26 • Number of events 3
|
7.7%
2/26 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
|
Investigations
Alanine aminotransferase increased
|
3.7%
1/27 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/27
|
7.7%
2/26 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/27
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
11.5%
3/26 • Number of events 3
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/27
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
11.5%
3/26 • Number of events 3
|
|
Infections and infestations
Urinary Tract Infection
|
3.7%
1/27 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
|
Nervous system disorders
Headache
|
11.1%
3/27 • Number of events 3
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
0.00%
0/26
|
|
Infections and infestations
Gastroenteritis Viral
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
11.5%
3/26 • Number of events 3
|
0.00%
0/26
|
|
General disorders
Chest Pain
|
0.00%
0/27
|
0.00%
0/26
|
11.5%
3/26 • Number of events 3
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
|
Investigations
Hepatice Enzyme Increased
|
0.00%
0/27
|
0.00%
0/26
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/27
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
11.5%
3/26 • Number of events 3
|
0.00%
0/26
|
|
Gastrointestinal disorders
Eructation
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
|
Gastrointestinal disorders
Asthenia
|
0.00%
0/27
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/27
|
0.00%
0/26
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
0.00%
0/26
|
0.00%
0/26
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/27
|
0.00%
0/26
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
0.00%
0/26
|
0.00%
0/26
|
|
Investigations
Blood Urine
|
0.00%
0/27
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
0.00%
0/26
|
|
Gastrointestinal disorders
Gastric Dilatation
|
0.00%
0/27
|
7.7%
2/26 • Number of events 2
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
|
Investigations
Blood Potassium Increased
|
0.00%
0/27
|
7.7%
2/26 • Number of events 2
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
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