Dyslipidemia
Conditions
Keywords
LCP-AtorFen, Non-HDL cholesterol, Triglycerides, HDL cholesterol, LDL cholesterol, Atorvastatin, Fenofibrate
Brief summary
The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a combination of atorvastatin and fenofibrate.
Detailed description
This is a multicenter, randomized, double-blind, 12 week study with a 52-week open-label follow-up to evaluate the safety and efficacy of LCP-AtorFen (the combination of atorvastatin and fenofibrate) in the treatment of hyperlipidemia. After a wash-out phase, eligible patients will be randomized on a 1:1:1 ratio to either LCP-AtorFen, atorvastatin or fenofibrate for 12 weeks. After the completion of the 12-week phase, all eligible patients will be offered to receive open-label LCP-AtorFen for another 52 weeks.
Interventions
DRUGLCP-AtorFen
40mg atorvastatin combined with 100mg fenofibrate in a tablet for once daily treatment of dyslipidemia and mixed dyslipidemia
DRUGatorvastatin
dyslipidemia and mixed dyslipidemia
DRUGfenofibrate
dyslipidemia and mixed dyslipidemia
Sponsors
Veloxis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. A diagnosis of dyslipidemia (non-HDL-C \>130 mg/dL and Triglycerides \> or equal to 150 mg/dL and \< or equal to 500 mg/dL). 2. Subject may be currently on a statin or other lipid-lowering therapy but must be willing and able to washout for 8 weeks if on a fibrate or high-dose niacin, 6 weeks if on a statin or low-dose niacin per day, or 4 weeks if on a bile acid sequestrant, ezetimibe, or \>1000 mg of fish oil per day. 3. Other inclusion criteria might apply
Exclusion criteria
1. TGs \> 500 mg/dL. 2. History of coronary heart disease (CHD), transient ischemic attacks, stroke or revascularization procedure in the six months prior. 3. Presence of an aortic aneurysm or resection of an aortic aneurysm within six months. 4. Poorly controlled diabetes mellitus (glycosylated hemoglobin \>8.0% )or diabetes mellitus requiring insulin therapy. 5. Known lipoprotein lipase impairment or deficiency or Apo C-II deficiency or familial dysbetalipoproteinemia. 6. History of pancreatitis. 7. Known allergy or sensitivity to statins or fibrates. 8. Poorly controlled hypertension. 9. Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy | baseline(randomization) to 12 weeks | Mean percent change from baseline to end-of-treatment (12 weeks) for non-HDL cholesterol and triglycerides and the mean percent change from baseline to end-of-treatment for HDL cholesterol for AtorFen 40/100mg fixed-dose combination tablet versus atorvastatin 40mg tablet. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy | baseline (week 0) to 12 weeks | Mean percent changes from baseline (Visit 3, Week 0) to end-of-treatment (Visit 6; Week 12) in non-HDL, HDL and LDL cholesterol by LCP-AtorFen versus fenofibrate monotherapy |
Countries
United States
Participant flow
Recruitment details
Subjects will be recruited from a combination of sources: advertising, clinical databases, clinical referrals, and the general subject population.
Pre-assignment details
The washout period for subjects on lipid-lowering therapy will be 4 to 8 weeks, depending on their regimen.
Participants by arm
| Arm | Count |
|---|---|
| LCP-AtorFen 40/100mg study drug arm Atorvastatin 40mg and fenofibrate 100mg | 73 |
| Atorvastatin 40mg active control arm atorvastatin 40mg | 74 |
| Fenofibrate 145mg active control arm fenofibrate 145mg | 73 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 6 | 4 | 10 |
Baseline characteristics
| Characteristic | Atorvastatin 40mg | Fenofibrate 145mg | LCP-AtorFen 40/100mg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 74 Participants | 73 Participants | 73 Participants | 220 Participants |
| Age, Continuous | 56.3 years STANDARD_DEVIATION 9.88 | 56.4 years STANDARD_DEVIATION 10.58 | 54.9 years STANDARD_DEVIATION 10.74 | 55.9 years STANDARD_DEVIATION 10.38 |
| Region of Enrollment United States | 74 participants | 73 participants | 73 participants | 220 participants |
| Sex: Female, Male Female | 39 Participants | 33 Participants | 33 Participants | 105 Participants |
| Sex: Female, Male Male | 35 Participants | 40 Participants | 40 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 43 / 73 | 49 / 74 | 48 / 73 |
| serious Total, serious adverse events | 1 / 73 | 0 / 74 | 2 / 73 |
Outcome results
Primary
Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy
Mean percent change from baseline to end-of-treatment (12 weeks) for non-HDL cholesterol and triglycerides and the mean percent change from baseline to end-of-treatment for HDL cholesterol for AtorFen 40/100mg fixed-dose combination tablet versus atorvastatin 40mg tablet.
Time frame: baseline(randomization) to 12 weeks
Population: Modified intent-to-treat population consisted of all subjects randomized who had at least one dose of study drug and one post-baseline (randomization) assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LCP-AtorFen 40/100mg | Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy | triglycerides | -49.1 percent change from baseline | Standard Deviation 24.46 |
| LCP-AtorFen 40/100mg | Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy | non-HDL | -44.8 percent change from baseline | Standard Deviation 16.2 |
| LCP-AtorFen 40/100mg | Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy | HDL | 19.7 percent change from baseline | Standard Deviation 21.38 |
| Atorvastatin 40mg | Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy | non-HDL | -40.2 percent change from baseline | Standard Deviation 17.3 |
| Atorvastatin 40mg | Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy | triglycerides | -28.9 percent change from baseline | Standard Deviation 32.25 |
| Atorvastatin 40mg | Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy | HDL | 6.5 percent change from baseline | Standard Deviation 18.77 |
Secondary
Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy
Mean percent changes from baseline (Visit 3, Week 0) to end-of-treatment (Visit 6; Week 12) in non-HDL, HDL and LDL cholesterol by LCP-AtorFen versus fenofibrate monotherapy
Time frame: baseline (week 0) to 12 weeks
Population: Modified intent-to-treat population consisted of all subjects randomized who had at least one dose of study drug and one post-baseline (randomization) assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LCP-AtorFen 40/100mg | Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy | non-HDL | -44.8 percent change from baseline | Standard Deviation 16.2 |
| LCP-AtorFen 40/100mg | Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy | LDL | -42.3 percent change from baseline | Standard Deviation 20.01 |
| LCP-AtorFen 40/100mg | Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy | HDL | 19.7 percent change from baseline | Standard Deviation 21.38 |
| Atorvastatin 40mg | Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy | non-HDL | -16.1 percent change from baseline | Standard Deviation 17.5 |
| Atorvastatin 40mg | Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy | LDL | -13.9 percent change from baseline | Standard Deviation 18.31 |
| Atorvastatin 40mg | Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy | HDL | 18.2 percent change from baseline | Standard Deviation 17.81 |