FAMILIAR HYPERCHOLESTEROLEMIA
Conditions
Interventions
Trade Name: EVOLOCUMAB
Product Name: EVOLOCUMAB
Product Code: EMEA/H/C/003766
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: EVOLOCUMAB
CAS Number: 1256937-27-5
Sponsors
SERVICIO DE NEFROLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: EVOLOCUMAB CONTRAINDICATIONS HOSPITALIZATION IN THREE PREVIOUS MONTHS CARDIOVASCULAR EVENTS IN THREE PREVIOUS MONTHS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: TO COMPARE THE EFFICACY AND SECURITY OF EVOLOCUMAB TREATMENT VS LDL-APHERESIS IN PATIENTS WITH FAMILIAR HYPERCHOLESTEROLEMIA AND HIGH RISK CARDIOVASCULAR 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): CHANGES OF APOB, APOA, HDL-CHOLESTEROL, TRIGLICERIDES AND LP(a) CHANGE OF INFLAMMATORY PARAMETERS CHANGE OF IMMUNOLOGIC PARAMETERS;Timepoint(s) of evaluation of this end point: 6 MONTHS | — |
Countries
Spain
Contacts
Public ContactServicio de Nefrologia
Hospital General Universitario Gregorio Marañon
Outcome results
None listed