Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2019-06-13
2022-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ATORVASTATIN
Atorvastatin 40mg caps: one daily. 3 patient visits: inclusion / week 2 / week 6. At each visit, blood sampling, stool sampling, ECG, to evaluate the pharmaco-metabolomic effects of the Statine
Atorvastatin 40mg Tablet
Patient participation for 6 weeks of treatment
PLACEBO
Placebo caps: one daily. 3 patient visits: inclusion / week 2 / week 6. At each visit, blood sampling, stool sampling, ECG to compare the pharmaco-metabolomic effects of the Statine between atorvastatin arm and placebo arm
Placebo comparator
Patient participation for 6 weeks of treatment
Interventions
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Atorvastatin 40mg Tablet
Patient participation for 6 weeks of treatment
Placebo comparator
Patient participation for 6 weeks of treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Contraception for women of childbearing age
Exclusion Criteria
* Renal insufficiency with creatinine clearance \<40ml/min
* Contra-indication to statins
* Previously known conditions affecting muscles, or digestive system
* Requirement of statins in secondary prevention
18 Years
75 Years
ALL
No
Sponsors
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Fondation Coeur et Recherche
UNKNOWN
ICAN Nutrition Education and Research
INDUSTRY
Fédération francaise de cardiologie
UNKNOWN
French Cardiology Society
OTHER
Responsible Party
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Principal Investigators
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Joe Elie SALEM, MD
Role: PRINCIPAL_INVESTIGATOR
CIC 1421 CHU Pitie Salpetriere
Locations
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CIC La Sapétrière
Paris, , France
CIC HEGP
Paris, , France
Countries
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Other Identifiers
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2016-02
Identifier Type: -
Identifier Source: org_study_id
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