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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01627665 |
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Date of registration:
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27/04/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban
DRIVING |
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Scientific title:
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New Oral Anticoagulant Drugs Dabigatran Etexilate and Rivaroxaban: Influence of Genetic Factors in Healthy Volunteers |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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64 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01627665 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Anne Blanchard, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CIC HEGP |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy Volunteers
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Intervention(s)
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Drug: D->R->C+D
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Drug: R->D->C+R
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Drug: D->R->C+R
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Drug: R->D->C+D
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Primary Outcome(s)
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AUC of plasma concentrations of the drugs
[Time Frame: over 24h after single oral dose]
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Secondary Outcome(s)
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PKD of the drugs
[Time Frame: over 24h after single oral dose]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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