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Evolocumab

Phase 3

Kideny Transplant Recipients With High Cardiovascular Risk Score | Small molecule | Other |ESSA Pharma Inc.|Last Updated: Dec 14, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04665830PCSK 9 Inhibition as Secondary Prevention in Renal Transplant PatientsPHASE3 COMPLETED 200May 1, 2018May 1, 2020Dec 14, 20201 Kuwait
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Study Endpoints
Primary Endpoints
Any major cardiovascular events
24 months

cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1ACTIVE_COMPARATOREvolocumab group, patients who are receiving this therapy for 12 months.
Group 2PLACEBO_COMPARATORThe Statin group includes patients who are maintained on statin therapy.
Interventions
NameTypeDescription
EvolocumabDRUGtreated patients with evolocumab for high cholesterol
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Eligibility Criteria
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:Kuwait
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