TREATMENT OF HYPERCHOLESTEROLEMIA WITH EVOLOCUMAB
Phase 1
- Conditions
- FAMILIAR HYPERCHOLESTEROLEMIATherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2016-002983-16-ES
- Lead Sponsor
- SERVICIO DE NEFROLOGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
PATIENTS OLDER THAN 18
FAMILIAR HYPERCHOLESTEROLEMIA WITH LDL-CHOLESTEROL GREATER THAN 100 MG/DL AND TREATMENT WITH HIGHER STATIN DOSAGE, AND PREVIOUS CARDIOVASCULAR EVENTS
PATIENTS WITH LDL-APHERESIS TREATMENT
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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
EVOLOCUMAB CONTRAINDICATIONS
HOSPITALIZATION IN THREE PREVIOUS MONTHS
CARDIOVASCULAR EVENTS IN THREE PREVIOUS MONTHS
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: TO COMPARE THE EFFICACY AND SECURITY OF EVOLOCUMAB TREATMENT VS LDL-APHERESIS IN PATIENTS WITH FAMILIAR HYPERCHOLESTEROLEMIA AND HIGH RISK CARDIOVASCULAR<br>TO EVALUATE THE COMBINATION OF LDL-APHERESIS WITH EVOLOCUMAB IN THE FAMILIAR HYPERCHOLESTEROLEMIA TREATMENT;Secondary Objective: TO COMPARE THE ANTIINFLAMMATORY AND IMMUNOLOGIC EFFECT OF LDL-APHERESIS VS EVOLOCUMAB;Primary end point(s): DECREASE OF LDL-CHOLESTEROL LEVELS IN PATIENTS IN TREATMENT WITH LDL-APHERESIS VS EVOLOCUMAB VS COMBINATION OF LDL-APHERESIS AND EVOLOCUMAB;Timepoint(s) of evaluation of this end point: 6 MONTHS
- Secondary Outcome Measures
Name Time Method Secondary end point(s): CHANGES OF APOB, APOA, HDL-CHOLESTEROL, TRIGLICERIDES AND LP(a)<br>CHANGE OF INFLAMMATORY PARAMETERS<br>CHANGE OF IMMUNOLOGIC PARAMETERS;Timepoint(s) of evaluation of this end point: 6 MONTHS