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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-007036-26 | EudraCT Number |
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The primary objective of this study is to evaluate whether ASA, the combination of ASA and clopidogrel, and darexaban, which have different effects on blood coagulation, influence each other in their effects. Also it will be investigated whether the blood levels of either drug are influenced by the presence of the other drug. In addition, the safety and tolerability of each drug and the combination of the drugs will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm A | Experimental | ASA, wash-out (w.o.), ASA + darexaban |
|
| Treatment arm B | Experimental | ASA + darexaban, w.o., ASA |
|
| Treatment arm C | Experimental | ASA, w.o., darexaban (double dose) + ASA |
|
| Treatment arm D | Experimental | darexaban (double dose) + ASA, w.o., ASA |
|
| Treatment arm E | Experimental | ASA + clopidogrel, w.o., ASA + clopidogrel + darexaban |
|
| Treatment arm F | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| darexaban | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pharmacodynamics of darexaban | Baseline and up to 24 hours after six days of dosing of darexaban, ASA, clopidogrel, or a combination |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pharmacodynamics of ASA and a combination of ASA and clopidogrel | Baseline and up to 24 hours after six days of dosing of darexaban, ASA, clopidogrel, or a combination | |
| Pharmacokinetics of ASA and the combination of ASA and clopidogrel assessed by plasma concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Manager | Astellas Pharma Europe B.V. | Study Chair |
| Principal Investigator | SGS Aster, Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Aster | Paris | 75015 | France |
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ASA + clopidogrel + darexaban, w.o., ASA + clopidogrel
|
| Treatment arm G | Experimental | ASA + clopidogrel, w.o., darexaban (double dose) + ASA + clopidogrel |
|
| Treatment arm H | Experimental | darexaban (double dose) + ASA + clopidogrel, w.o., ASA + clopidogrel |
|
| darexaban (double dose) | Drug | oral |
|
|
| Acetyl Salicylic Acid | Drug | oral |
|
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| clopidogrel | Drug | oral |
|
|
| Plasma samples are taken until 24 hours after six days of dosing of ASA, a combination of ASA and clopidogrel, or the combination with darexaban |
| Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events | 6 days for each of the 2 treatment periods |
| ID | Term |
|---|---|
| C569750 | darexaban |
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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