Trial Outcomes & Findings for 12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia (NCT NCT00664859)
NCT ID: NCT00664859
Last Updated: 2020-03-24
Results Overview
Mean percent changes in non-HDL cholesterol, HDL cholesterol, TG levels from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12 of DB study) to end of treatment (Week 52)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
140 participants
Primary outcome timeframe
52 weeks from DB baseline and 40 weeks from OL baseline
Results posted on
2020-03-24
Participant Flow
Of the 192 subjects who completed the double-blind (DB) period, 140 rolled over into the extension study and received at least one dose of open-label (OL) study drug to form the safety population.
Participant milestones
| Measure |
LCP-AtorFen 40/100 mg
Subjects randomized to LCP-AtorFen 40/100 mg/day in the DB portion of the study
|
Atorvastatin 40 mg
Subjects randomized to Atorvastatin 40 mg/day in the DB portion of the study
|
Fenofibrate 145 mg
Subjects randomized to Fenofibrate 145 mg/day in the DB portion of the study
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
45
|
44
|
|
Overall Study
COMPLETED
|
34
|
35
|
23
|
|
Overall Study
NOT COMPLETED
|
17
|
10
|
21
|
Reasons for withdrawal
| Measure |
LCP-AtorFen 40/100 mg
Subjects randomized to LCP-AtorFen 40/100 mg/day in the DB portion of the study
|
Atorvastatin 40 mg
Subjects randomized to Atorvastatin 40 mg/day in the DB portion of the study
|
Fenofibrate 145 mg
Subjects randomized to Fenofibrate 145 mg/day in the DB portion of the study
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
3
|
|
Overall Study
DB Study (LCP-AtorFen-2001) AE
|
6
|
4
|
4
|
|
Overall Study
Noncompliance with protocol
|
1
|
0
|
4
|
|
Overall Study
Laboratory abnormality
|
2
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
1
|
|
Overall Study
Other
|
0
|
1
|
2
|
Baseline Characteristics
12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia
Baseline characteristics by cohort
| Measure |
LCP-AtorFen 40/100mg
n=51 Participants
Data presented by previous double-blind study assignment
|
Atorvastatin 40 mg
n=45 Participants
Data presented by previous double-blind study assignment
|
Fenofibrate 145 mg
n=44 Participants
Data presented by previous double-blind study assignment
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 10.86 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 9.03 • n=7 Participants
|
57.2 years
STANDARD_DEVIATION 11.23 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 10.41 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Amer. Indian /Alaskan
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hawaiian/Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
46 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 52 weeks from DB baseline and 40 weeks from OL baselinePopulation: Modified intent-to-treat population
Mean percent changes in non-HDL cholesterol, HDL cholesterol, TG levels from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12 of DB study) to end of treatment (Week 52)
Outcome measures
| Measure |
LCP-AtorFen 40/100mg
n=51 Participants
Data presented by previous double-blind study assignment
|
Atorvastatin 40 mg
n=44 Participants
Data presented by previous double-blind study assignment
|
Fenofibrate 145 mg
n=43 Participants
Data presented by previous double-blind study assignment
|
|---|---|---|---|
|
Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment
HDL cholesterol change from DB baseline
|
22.1 percent change
Standard Deviation 21.7
|
16.3 percent change
Standard Deviation 18.67
|
17.5 percent change
Standard Deviation 20.21
|
|
Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment
HDL cholesterol change from OL baseline
|
2.1 percent change
Standard Deviation 16.9
|
10.1 percent change
Standard Deviation 17.77
|
-2.4 percent change
Standard Deviation 15.4
|
|
Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment
Non-HDL cholesterol, change from DB baseline
|
-48.2 percent change
Standard Deviation 13.58
|
-43.6 percent change
Standard Deviation 18.18
|
-42.0 percent change
Standard Deviation 20.49
|
|
Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment
Non-HDL cholesterol change from OL baseline
|
2.6 percent change
Standard Deviation 22.39
|
2.8 percent change
Standard Deviation 33.67
|
-29.6 percent change
Standard Deviation 26.92
|
|
Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment
Triglycerides change from DB baseline
|
-53.1 percent change
Standard Deviation 25.31
|
-51.2 percent change
Standard Deviation 23.23
|
-42.1 percent change
Standard Deviation 29.96
|
|
Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment
Triglycerides change from OL baseline
|
11.4 percent change
Standard Deviation 65.36
|
-19.1 percent change
Standard Deviation 40.42
|
-5.2 percent change
Standard Deviation 53.27
|
SECONDARY outcome
Timeframe: 52 weeks from DB baseline and 40 weeks from OL baselineMean percent changes in LDL cholesterol, VLDL, total cholesterol, Apo A-1, and Apo B from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12) to end-of-treatment (Week 52)
Outcome measures
| Measure |
LCP-AtorFen 40/100mg
n=51 Participants
Data presented by previous double-blind study assignment
|
Atorvastatin 40 mg
n=44 Participants
Data presented by previous double-blind study assignment
|
Fenofibrate 145 mg
n=43 Participants
Data presented by previous double-blind study assignment
|
|---|---|---|---|
|
Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment
Apo A-1 change from DB baseline
|
3.2 Percent change
Standard Deviation 13.21
|
1.0 Percent change
Standard Deviation 9.88
|
0.4 Percent change
Standard Deviation 12.5
|
|
Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment
Apo-A-1 change from OL baseline
|
-1.4 Percent change
Standard Deviation 8.11
|
1.9 Percent change
Standard Deviation 13.62
|
-5.1 Percent change
Standard Deviation 11.36
|
|
Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment
Apo B change from DB baseline
|
-42.4 Percent change
Standard Deviation 11.85
|
-38.9 Percent change
Standard Deviation 16.26
|
-36.8 Percent change
Standard Deviation 18.81
|
|
Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment
Apo B change from OL baseline
|
3.1 Percent change
Standard Deviation 17.69
|
-1.5 Percent change
Standard Deviation 25.14
|
-25.5 Percent change
Standard Deviation 21.59
|
|
Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment
LDL-C change from DB baseline
|
-44.8 Percent change
Standard Deviation 15.92
|
-39.3 Percent change
Standard Deviation 20.04
|
-40.9 Percent change
Standard Deviation 22.0
|
|
Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment
LDL-C change from OL baseline
|
2.1 Percent change
Standard Deviation 25.09
|
14 Percent change
Standard Deviation 36.29
|
-33.6 Percent change
Standard Deviation 24.26
|
|
Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment
VLDL-C change from DB baseline
|
-53.6 Percent change
Standard Deviation 23.98
|
-51.1 Percent change
Standard Deviation 23.07
|
-42.0 Percent change
Standard Deviation 29.94
|
|
Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment
VLDL-C change from OL baseline
|
12.7 Percent change
Standard Deviation 69.42
|
-18.7 Percent change
Standard Deviation 39.97
|
-5.5 Percent change
Standard Deviation 51.98
|
|
Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment
Total-C change from DB baseline
|
-36.5 Percent change
Standard Deviation 11.07
|
-33.8 Percent change
Standard Deviation 14.6
|
-32.8 Percent change
Standard Deviation 16.08
|
|
Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment
Total-C change from OL baseline
|
1.5 Percent change
Standard Deviation 12.95
|
4.6 Percent change
Standard Deviation 24.54
|
-24.4 Percent change
Standard Deviation 19.04
|
Adverse Events
LCP-AtorFen 40/100mg
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Atorvastatin 40 mg
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Fenofibrate 145 mg
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LCP-AtorFen 40/100mg
n=51 participants at risk
Data presented by previous double-blind study assignment
|
Atorvastatin 40 mg
n=45 participants at risk
Data presented by previous double-blind study assignment
|
Fenofibrate 145 mg
n=44 participants at risk
Data presented by previous double-blind study assignment
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.0%
1/51
|
0.00%
0/45
|
0.00%
0/44
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/51
|
0.00%
0/45
|
2.3%
1/44
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
2.0%
1/51
|
0.00%
0/45
|
0.00%
0/44
|
|
Injury, poisoning and procedural complications
Fracture treatment
|
2.0%
1/51
|
0.00%
0/45
|
0.00%
0/44
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/51
|
0.00%
0/45
|
2.3%
1/44
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/51
|
2.2%
1/45
|
0.00%
0/44
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/51
|
0.00%
0/45
|
2.3%
1/44
|
|
Investigations
Elevated ALT
|
0.00%
0/51
|
0.00%
0/45
|
2.3%
1/44
|
Other adverse events
| Measure |
LCP-AtorFen 40/100mg
n=51 participants at risk
Data presented by previous double-blind study assignment
|
Atorvastatin 40 mg
n=45 participants at risk
Data presented by previous double-blind study assignment
|
Fenofibrate 145 mg
n=44 participants at risk
Data presented by previous double-blind study assignment
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/51
|
13.3%
6/45
|
2.3%
1/44
|
|
Infections and infestations
Nasopharyngitis
|
11.8%
6/51
|
20.0%
9/45
|
20.5%
9/44
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
3/51
|
13.3%
6/45
|
9.1%
4/44
|
|
Endocrine disorders
Blood glucose increased
|
2.0%
1/51
|
2.2%
1/45
|
9.1%
4/44
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.0%
1/51
|
4.4%
2/45
|
6.8%
3/44
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/51
|
6.7%
3/45
|
0.00%
0/44
|
Additional Information
Director, Regulatory Affairs
Veloxis Pharmaceuticals, Inc.
Phone: 919-591-3090
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The study is a multicenter collaborative investigation and the clinical trial results are to be published as a collaborative manuscript. Authorship will reflect varying levels of individual contribution to the study by the individual PI's.
- Publication restrictions are in place
Restriction type: OTHER