| Trial ID: | L0819 |
| Source ID: | NCT04397653
|
| Associated Drug: |
Evolocumab
|
| Title: |
Evolocumab Plus Ezetimibe in High Risk Haemodialized Statin Intolerant Patients
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hypercholesterolemia|Chronic Kidney Disease Requiring Chronic Dialysis
|
| Interventions: |
DRUG: Evolocumab|DRUG: Placebo|DRUG: Ezetimibe
|
| Outcome Measures: |
Primary: LDL cholesterol reduction dichotomic, change in LDL cholesterol levels ≥ 20 mg/dL from baseline, 24 weeks | Secondary: LDL cholesterol reduction time-points, change in LDL cholesterol levels from baseline, 4 weeks, 12 weeks, 24 weeks|HDL cholesterol reduction, change in HDL cholesterol levels from baseline, 24 weeks|non-HDL cholesterol reduction, change in non-HDL cholesterol levels from baseline, 24 weeks|Triglycerides reduction, change in triglycerides levels from baseline, 24 weeks|LDL cholesterol target achieving, percent of patients achieving an LDL cholesterol less than 70 mg/dL, 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Policlinico Casilino ASL RMB | Collaborators: IRCCS San Raffaele
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-05-04
|
| Completion Date: |
2020-12-14
|
| Results First Posted: |
|
| Last Update Posted: |
2020-05-26
|
| Locations: |
Policlinico Casilino, Rome, 00169, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT04397653
|
