A study to evaluate the effect and safety of a 4 week treatment plan of Alirocumab in patients with high cholesterol
- Conditions
- Primary HypercholesterolemiaMedDRA version: 17.0Level: LLTClassification code 10020604Term: HypercholesterolemiaSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2013-002343-29-GB
- Lead Sponsor
- Regeneron Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 803
1. Men and women > age 18 or legal age of majority with elevated LDL-C.
2. Patients not having adequate control of their hypercholesterolemia, defined as follows: for moderate and high CVD risk, LDL-C =100 mg/dL, and for very high CVD risk, LDL-C = 70 mg/dL. Patients who are not on statin therapy must be at moderate CVD risk and must have LDL-C <160 mg/dL (<4.14 mmol/L). Patients who are statin intolerant may be at moderate CVD risk or greater. Patients who are statin intolerant must have LDL-C <160 mg/dL (<4.14 mmol/L), if they are not receiving any other non-statin LMT. There is no upper limit for LDL-C for patients who are statin intolerant and are receiving clinically appropriate
lipid-lowering therapy (as they are already on standard of care). See protocol for CVD risk categories and definition of statin intolerance.
3. If on statin therapy, patients on the following medications/doses for at least 28 days prior to the screening visit are allowed: atorvastatin 40 mg or 80 mg, rosuvastatin 20 mg or 40 mg, or simvastatin 80 mg (must be on stable dose of simvastatin for at least 1 year), or their maximally tolerated dose of 1 of these 3 statins.
4. Willing and able to comply with clinic visits and study-related procedures.
5. Provide signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 525
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 175
1. Patient with homozygous FH (clinically or by previous genotyping)
2. Currently taking a statin that is not atorvastatin, rosuvastatin, or simvastatin
3. Use of fibrates other than fenofibrate within 6 weeks of the screening visit
4. Use of allowed LMTs (eg, omega-3 fatty acids, cholesterol absorption inhibitors [eg, ezetimibe], bile acid resins, niacin, and plant stanols/sterols [such as those found in Benecol®, flax seed oil, or psyllium]) that have not been at a stable dose/regimen for at least 4 weeks prior to the screening visit
5. Use of nutraceutical products or over-the-counter therapies that may affect lipids and that have not been at a stable dose/amount for at least 4 weeks prior to the screening visit
6. Use of red yeast rice products within 4 weeks of the screening visit or between screening and randomization visits
7. Uncontrolled hypothyroidism
8. Uncontrolled blood pressure (systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg) at the screening visit
9. Patient who has received plasmapheresis treatment within 2 months prior to the screening visit, or has plans to receive it during the study
10. Recent (within 3 months prior to the screening visit) myocardial infarction, unstable angina leading to hospitalization, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease
11. Planning to undergo scheduled PCI, CABG, or carotid or peripheral revascularization during the study
12. Known history of a hemorrhagic stroke
13. History of New York Heart Association Class III or IV heart failure within 12 months prior to the screening visit.
14. Newly diagnosed diabetes (within 3 months prior to the screening visit) or poorly controlled diabetes (hemoglobin A1c [HbA1c] >9% at the screening visit)
15. History of bariatric surgery within 12 months prior to the screening visit
16. Unstable weight, defined by a variation >5 kg within 2 months prior to the screening visit
17. Known history of loss of function of PCSK9 (ie, genetic mutation or sequence variation)
18. Use of systemic corticosteroids, unless used as replacement therapy for pituitary/adrenal disease with a stable regimen for at least 6 weeks prior to randomization
19. Use of continuous estrogen or testosterone hormone replacement therapy, unless the regimen has been stable for 6 weeks prior to the screening visit and there are no plans to change the regimen during the study
20. History of cancer within the past 5 years, except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer
21. Known history of positive test for human immunodeficiency virus (HIV)
22. Has been previously treated with at least 1 dose of alirocumab or any other anti-PCSK9 monoclonal antibody in other clinical studies
23. Has taken any active investigational drugs within 1 month or 5 half-lives, whichever is longer; however, patients who have taken anti-PCSK9 therapy at any time are excluded
24. Conditions/situations such as:
? Any clinically significant abnormality identified at the time of screening that in the judgment of the investigator or any sub-investigator would preclude safe completion of the study or constrain assessment of endpoints, such as major systemic diseases or patients with short life expecta
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method