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Echographic measurements, Blood samples

Phase 3

Hypercholesterolaemia | Unknown | Metabolic |Viatris Inc.|Trials Updated: Feb 18, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment400

FDA Designations

No designations recorded

Echographic measurements, Blood samples clinical trials

Echographic measurements, Blood samples · 1 trial · 1 indication

Phase 3 1
NCT00163163Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal WomenHypercholesterolaemia
COMPLETED400 Analytics
PHASE3COMPLETED
Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women
Hypercholesterolaemia
NCT00163163400
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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 to 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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