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Echographic measurements, Blood samples

Phase 3

Hypercholesterolaemia | Unknown | Metabolic |Pfizer, Inc.|Last Updated: Feb 18, 2021

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
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment400
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00163163Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal WomenPHASE3 COMPLETED 400Jan 1, 2003Jul 1, 2006Feb 18, 202169 Belgium, France +1
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Study Endpoints
Primary Endpoints
Mean change in carotid IMT from baseline to month 12.
Secondary Endpoints
Mean change from baseline to month 12 of carotid internal diameter (ID)
wall cross sectional area (WCSA); carotid arterial mass (AM)
pulse pressure (PP); cross sectional distensibility and compliance (DC and CC)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Echographic measurementsPROCEDURE -
Blood samplesPROCEDURE -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites69

Inclusion Criteria: * Postmenopausal women defined as having Age =\< 70 years with documented menopause * Fasting LDL cholesterol 130 mg/ dl (3.37 mmol/l)and =\< 190 mg/ dl (4.92 mmol/l) after 6 weeks of diet * Triglycerides =\< 4 g/l(4.52 mmol/l) * Informed, written consent Exclusion Criteria: *...

Countries:BelgiumFranceNetherlands
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