Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Evolocumab · 1 trial · 1 indication
cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization
| Arm | Type | Description |
|---|---|---|
| Group 1 | ACTIVE_COMPARATOR | Evolocumab group, patients who are receiving this therapy for 12 months. |
| Group 2 | PLACEBO_COMPARATOR | The Statin group includes patients who are maintained on statin therapy. |
| Name | Type | Description |
|---|---|---|
| Evolocumab | DRUG | treated patients with evolocumab for high cholesterol |
Inclusion Criteria: * 1\. Signed informed consent, 2. Male or female Kuwaiti older than 30 and younger than ≤ 80 years of age at the signing of informed consent 3. History of clinically evident cardiovascular disease(diagnosis of myocardial infarction; non-hemorrhagic stroke or symptomatic peripher...
Evolocumab is being studied for use in kidney transplant recipients with a high cardiovascular risk score. It is an investigational small molecule being evaluated as secondary prevention in this patient population. The drug is currently in Phase 3 clinical development, though the specific trial has been completed.
Evolocumab targets PCSK9, as indicated by the clinical trial title 'PCSK 9 Inhibition as Secondary Prevention in Renal Transplant Patients'. By inhibiting PCSK9, the drug is intended to lower cardiovascular risk in kidney transplant recipients with a high cardiovascular risk score.
Evolocumab is being developed by ESSA Pharma Inc., a biopharmaceutical company traded on the NASDAQ under the ticker EPIX. The company is conducting clinical research on this drug for the indication of kidney transplant recipients with high cardiovascular risk.
Evolocumab is in Phase 3 clinical development. The Phase 3 trial, NCT04665830, has been completed. The drug is investigational and has not been reported as approved for this indication. It is being studied as secondary prevention in renal transplant patients.
Evolocumab has one completed Phase 3 clinical trial, NCT04665830, titled 'PCSK 9 Inhibition as Secondary Prevention in Renal Transplant Patients'. This randomized, placebo-controlled trial enrolled 200 participants in Kuwait and studied the drug in kidney transplant recipients with a high cardiovascular risk score.