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NCT04659525
Evolocumab Plus Ezetimibe in Haemodialized Statin-intolerant Patients With Hypercholesterolemia
Phase 4 trial testing Evolocumab in Hypercholesterolemia in 50 participants. Status unknown.
30 November 2021
Quick facts
| Lead sponsor | Policlinico Casilino ASL RMB |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 November 2020 |
| Primary completion | 30 November 2021 |
| Estimated completion | 30 December 2021 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Evolocumab (EVOLOCUMAB) — full drug profile →
- Ezetimibe (EZETIMIBE) — full drug profile →
- Placebo
Conditions studied
- Hypercholesterolemia — all drugs for Hypercholesterolemia →
- CKD Stage 5 — all drugs for CKD Stage 5 →
- Chronic Kidney Disease Requiring Chronic Dialysis — all drugs for Chronic Kidney Disease Requiring Chronic Dialysis →
Sponsor
Policlinico Casilino ASL RMB
Who can join
Adults 18 to 80, any sex, with Hypercholesterolemia or CKD Stage 5. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol, reducing in turn the risk of cardiovascular events. Whether evolcumab is effective in haemodialized patients is uncertain. The investigators will conduct a randomized, double-blind, placebo-controlled trial to assess the feasibility, safety, and LDL-C-lowering efficacy of evolocumab in high cardiovascular risk haemodialized statin intolerant patients with hypercholesterolemia. Patients will be randomly assigned to receive evolocumab (140 mg subcutaneous every 2 weeks + ezetimibe 10 mg per os daily) or matching placebo (subcutaneous every 2 weeks + ezetimibe 10 mg per os daily) for 24 weeks. The primary efficacy end point will be the proportion of patients that will reduce LDL-C \< 55 mg/dL in the evolocumab group compared to placebo at 24 weeks. The key secondary efficacy end points will be: the reduction of LDL-C from baseline at 4, 6 and 12 weeks; the reduction of HDL-C, non-HDL cholesterol and triglycerides from baseline at 24 weeks. Every adverse event (serious and non-serious) correlated to drug infusion will be recorded (safety end-point).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04659525
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT05974345 — In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established C · completed
Other recruiting trials for Hypercholesterolemia
Currently open trials in the same condition.
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- NCT07374861 — Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy · recruiting
- NCT07295327 — Effect of Two Food Supplements on Lipid Profile in Patients With Mild Hypercholesterolemia · NA · recruiting
- NCT06568601 — Pharmacogenomic Informed Statin Prescribing · NA · recruiting
- NCT06423365 — A Tool to Help Patients With Muscle Symptoms After Taking a Statin Medication. · NA · active not recruiting
Other Policlinico Casilino ASL RMB trials
Trials by the same sponsor.
- NCT05751330 — Italian Cardioneuroablation Study for Neurocardiogenic Syncope Patients · NA · unknown
- NCT04328649 — Clinical, Structural and Mechanical Features in Patients With Left Bundle Branch Block. · unknown
- NCT04397653 — Evolocumab Plus Ezetimibe in High Risk Haemodialized Statin Intolerant Patients · Phase 4 · unknown
- NCT04320134 — cliNIcal sCEnarios and Pathophysiology of Atrial Fibrillation · unknown
- NCT04163588 — Sequential Nephron Blockade in Acute Heart Failure · Phase 3 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04659525 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Policlinico Casilino ASL RMB
- Last refreshed: 17 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04659525.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing