Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban
NCT ID: NCT01627665
Last Updated: 2014-10-09
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
PHASE2/PHASE3
64 participants
INTERVENTIONAL
2011-10-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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D->R->C+R
sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with rivaroxaban
D->R->C+R
one oral dose DABIGATRAN 300 mg -\> RIVAROXABAN 40 mg -\> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg
D->R->C+D
sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with Dabigatran
D->R->C+D
one oral dose DABIGATRAN 300 mg -\> RIVAROXABAN 40 mg -\> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg
R->D->C+D
sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with Dabigatran
R->D->C+D
RIVAROXABAN 40 mg -\> one oral dose DABIGATRAN 300 mg -\> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg
R->D->C+R
sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with rivaroxaban
R->D->C+R
RIVAROXABAN 40 mg -\> one oral dose DABIGATRAN 300 mg -\> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg
Interventions
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D->R->C+R
one oral dose DABIGATRAN 300 mg -\> RIVAROXABAN 40 mg -\> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg
D->R->C+D
one oral dose DABIGATRAN 300 mg -\> RIVAROXABAN 40 mg -\> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg
R->D->C+D
RIVAROXABAN 40 mg -\> one oral dose DABIGATRAN 300 mg -\> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg
R->D->C+R
RIVAROXABAN 40 mg -\> one oral dose DABIGATRAN 300 mg -\> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg
Eligibility Criteria
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Inclusion Criteria
* Aged between 18-35 years inclusive
* Male
* Caucasian
* Body mass index (BMI) between 18 and 27 kg per m² inclusive.
18 Years
45 Years
MALE
Yes
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Anne Blanchard, MD
Role: PRINCIPAL_INVESTIGATOR
CIC HEGP
Locations
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CIC Hopital europeen george pompidou
Paris, Paris, France
Countries
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References
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Foulon-Pinto G, Jourdi G, Perrin J, Abdoul J, Paris G, Gouin-Thibault I, Curis E, Lecompte T, Siguret V. Study of thrombin generation with St Genesia to evaluate xaban pharmacodynamics: Analytical performances over 18 months. Int J Lab Hematol. 2021 Aug;43(4):821-830. doi: 10.1111/ijlh.13443. Epub 2020 Dec 28.
Marques P, Courand PY, Gouin-Thibault I, Zhygalina V, Bergerot D, Salem JE, Funck-Brentano C, Loriot MA, Azizi M, Blanchard A. P-glycoprotein influences urinary excretion of aldosterone in healthy individuals. J Hypertens. 2019 Nov;37(11):2225-2231. doi: 10.1097/HJH.0000000000002150.
Other Identifiers
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P081208
Identifier Type: -
Identifier Source: org_study_id
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