Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban

NCT ID: NCT01627665

Last Updated: 2014-10-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-06-30

Brief Summary

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The study will address the impact of genetical variation of a protein involved in the intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.

Detailed Description

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The study will address the impact of genetical variation of a protein involved in the intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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D->R->C+R

sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with rivaroxaban

Group Type ACTIVE_COMPARATOR

D->R->C+R

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

D->R->C+D

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

R->D->C+D

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

R->D->C+R

Intervention Type DRUG

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

Intervention Type DRUG

D->R->C+D

one oral dose DABIGATRAN 300 mg -\> RIVAROXABAN 40 mg -\> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg

Intervention Type DRUG

R->D->C+D

RIVAROXABAN 40 mg -\> one oral dose DABIGATRAN 300 mg -\> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg

Intervention Type DRUG

R->D->C+R

RIVAROXABAN 40 mg -\> one oral dose DABIGATRAN 300 mg -\> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy participants
* Aged between 18-35 years inclusive
* Male
* Caucasian
* Body mass index (BMI) between 18 and 27 kg per m² inclusive.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

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.

Reference Type DERIVED
PMID: 33369212 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31157746 (View on PubMed)

Other Identifiers

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P081208

Identifier Type: -

Identifier Source: org_study_id

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