The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen including an alirocumab starting dose of 150 mg Q4W as add-on to non-statin lipid modifying background therapy or as…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
hypercholesterolemie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percent change in calculated LDL-C from baseline to week 16.
Secondary outcome
The percent change in LDL-C from baseline to week 12.
The percent change of other lipid parameters from baseline to week 12, week 16
and week 24.
Background summary
Hypercholesterolemia, particularly an increase in low-density lipoprotein
cholesterol (LDL-C) levels, constitutes a major risk for the development of
atherosclerosis and coronary heart disease (CHD). Current LDL-C lowering
medications include statins, ezetimibe (EZE), fibrates, niacin, and bile acid
sequestrants. While statins are proven to be well tolerated agents there is a
subset of patients who are intolerant to statin therapy and/or who suffer from
side effects. Sanofi is developing a new drug to lower LDL-cholesterol,
alirocumab. Alirocumab blocks PCSK9 binding to the LDL-receptor, which can
potentially benefit patients with hypercholesterolemia by decreasing their
plasma LDL-C levels.
Study objective
The primary objective of the study is to demonstrate the reduction of
low-density lipoprotein cholesterol (LDL-C) by a regimen including an
alirocumab starting dose of 150 mg Q4W as add-on to non-statin lipid modifying
background therapy or as monotherapy in comparison with placebo in patients
with primary hypercholesterolemia not treated with a statin.
Study design
A randomized, double-blind, placebo-controlled, parallel-group study.
Intervention
- Alirocumab 150 mg every 4 weeks
- Alirocumab 75 mg every 2 weeks
- Placebo every 2 weeks
Study burden and risks
The most common side effects of alirocumab reported in previous completed
studies of alirocumab in patients who received at least one dose of alirocumab
include: injection site reactions, dizziness, headache, nausea and diarrhea.
Kampenringweg 45E
Gouda 2803 PE
NL
Kampenringweg 45E
Gouda 2803 PE
NL
Listed location countries
Age
Inclusion criteria
Patients with primary hypercholesterolemia (heFH or non-FH) not adequately controlled with their non statin lipid modifying therapy or diet.
Exclusion criteria
- LDL-C < 70 mg/dL (1.81 mmol/L) and very high cardiovascular (CV) risk patients who are intolerant to statins at the screening visit
- LDL-C < 100 mg/dL (< 2.59 mmol/L) and at high or moderate CV risk patients at the screening visit
- Patients not fulfilling the statin intolerant definition and at moderate CV risk with LDL-C < 100 mg/dL (<2.59 mmol/L) at the screening visit
- LDL-C >= 160 mg/dL (>= 4.1 mmol/L) if receiving diet only
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-002659-14-NL |
| CCMO | NL46239.018.13 |
| Other | Zie sectie J |