| Primary | Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients | Final extent IPA from pre-dose baseline was calculated using the following formula for Adenosine Diphosphate (ADP)-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) Platelet Aggregation (PA) was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit. | Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan | Posted | | Mean | Standard Deviation | percentage inhibition | | Week 4 | | | | ID | Title | Description |
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| OG000 | AZD6140 45 mg bd | AZD6140 45 mg twice daily in Japanese patients | | OG001 | AZD6140 90 mg bd | AZD6140 90 mg twice daily in Japanese patients | | OG002 | Clopidogrel 75 mg od | Clopidogrel 75 mg once daily |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00064.5± 14.8
- OG00173.0± 14.2
- OG00238.9± 20.7
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| Primary | IPA Final Extent at 4 Hours Post Dose on Week 4 in Japanese Patients | Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit. | Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan | Posted | | Mean | Standard Deviation | percentage inhibition | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AZD6140 45 mg bd | AZD6140 45 mg twice daily in Japanese patients | | OG001 | AZD6140 90 mg bd | AZD6140 90 mg twice daily in Japanese patients | | OG002 | Clopidogrel 75 mg od | Clopidogrel 75 mg once daily |
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| Primary | IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients | Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit. | Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan | Posted | | Mean | Standard Deviation | percentage inhibition | | Week 4 | | | | ID | Title | Description |
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| OG000 | AZD6140 45 mg bd | AZD6140 45 mg twice daily | | OG001 | AZD6140 90 mg bd | AZD6140 90 mg twice daily | | OG002 | Clopidogrel 75 mg od | Clopidogrel 75 mg once daily |
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| Primary | IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients | Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit. | Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan | Posted | | Mean | Standard Deviation | percentage inhibition | | Week 4 | | | | ID | Title | Description |
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| OG000 | Arm 1 - AZD6140 45 mg bd | AZD6140 45 mg twice daily | | OG001 | AZD6140 90 mg bd | AZD6140 90 mg twice daily | | OG002 | Clopidogrel 75 mg od | Clopidogrel 75 mg once daily |
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| Primary | IPA Final Extent at 24 Hours Post Dose on Week 4 in Japanese Patients | Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit. | Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan | Posted | | Mean | Standard Deviation | percentage inhibition | | Week 4 | | | | ID | Title | Description |
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| OG000 | AZD6140 45 mg bd | AZD6140 45 mg twice daily | | OG001 | AZD6140 90 mg bd | AZD6140 90 mg twice daily | | OG002 | Clopidogrel 75 mg od | Clopidogrel 75 mg once daily |
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| Secondary | AZD6140 (Cmax) at Week 4 | Maximum plasma AZD6140 concentration | Only Japanese participants who had IPA data at Week 4 were considered in this analysis | Posted | | Geometric Mean | Standard Deviation | ng/mL | | Week 4 | | | | ID | Title | Description |
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| OG000 | AZD6140 45 mg bd in Japanese Patients | AZD6140 45 mg twice daily in Japanese patients | | OG001 | AZD6140 45 mg bd in Non-Japanese Patients | AZD6140 45 mg twice daily in non-Japanese patients | | OG002 | AZD6140 90 mg bd in Japanese Patients | AZD6140 90 mg twice daily in Japanese patients | | OG003 | AZD6140 90 mg bd in Non-Japanese Patients | AZD6140 90 mg twice daily in non-Japanese patients |
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| Secondary | AZD6140 (AUC0-tau) at Week 4 | Area under the plasma concentration curve of AZD6140 from time zero to dosing interval | In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory. | Posted | | Geometric Mean | Standard Deviation | ng.h/mL | | Week 4 | | | | ID | Title | Description |
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| OG000 | AZD6140 45 mg bd in Japanese Patients | AZD6140 45 mg twice daily in Japanese patients | | OG001 | AZD6140 45 mg bd in Non-Japanese Patients | AZD6140 90 mg twice daily in non-Japanese patients | | OG002 | AZD6140 90 mg bd in Japanese Patients | AZD6140 90 mg twice daily in Japanese patients | | OG003 | AZD6140 90 mg bd in Non-Japanese Patients | AZD6140 45 mg twice daily in non-Japanese patients |
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| Secondary | AZD6140 (Tmax) at Week 4 | Time to reach peak or maximum concentration of AZD6140 following AZD6140 administration | In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory. | Posted | | Median | Full Range | hour | | Week 4 | | | | ID | Title | Description |
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| OG000 | AZD6140 45 mg bd in Japanese Patients | AZD6140 45 mg twice daily in Japanese patients | | OG001 | AZD6140 45 mg bd in Non-Japanese Patients | AZD6140 45 mg twice daily in non-Japanese patients | | OG002 | AZD6140 90 mg bd in Japanese Patients | AZD6140 90 mg twice daily in Japanese patients | | OG003 | AZD6140 90 mg bd in Non-Japanese Patients | AZD6140 90 mg twice daily in non-Japanese patients |
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| Secondary | AR-C124910XX (Cmax) at Week 4 | Maximum plasma concentration of AZD6140 drug metabolite AR-C124910XX | In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory. | Posted | | Geometric Mean | Standard Deviation | ng/mL | | Week 4 | | | | ID | Title | Description |
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| OG000 | AZD6140 45 mg bd in Japanese Patients | AZD6140 45 mg twice daily in Japanese patients | | OG001 | AZD6140 45mg bd in Non-Jpanese Patients | AZD6140 45 mg twice daily in non-Japanese patients | | OG002 | AZD6140 90 mg bd in Japanese Patients | AZD6140 90 mg twice daily in Japanese patients | | OG003 | AZD6140 90 mg bd in Non-Jpanese Patients | AZD6140 90 mg twice daily in non-Japanese patients |
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| Secondary | AR-C124910XX (AUC0-tau) at Week 4 | Area under the plasma concentration curve of AZD6140 drug metabolite AR-C124910XX from time zero to dosing interval | In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory. | Posted | | Geometric Mean | Standard Deviation | ng.h/mL | | Week 4 | | | | ID | Title | Description |
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| OG000 | AZD6140 45 mg bd in Japanese Patients | AZD6140 45 mg twice daily in Japanese patients | | OG001 | AZD6140 45 mg bd in Non-Japanese Patients | AZD6140 45 mg twice daily in non-Japanese patients | | OG002 | AZD6140 90 mg bd in Japanese Patients | AZD6140 90 mg twice daily in Japanese patients | | OG003 | AZD6140 90 mg bd in Non-Japanese Patients | AZD6140 90 mg twice daily in non-Japanese patients |
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| Secondary | AR-C124910XX (Tmax) at Week 4 | Time to reach peak or maximum concentration of AZD6140 drug metabolite AR-C124910XX following AZD6140 administration | In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory. | Posted | | Median | Full Range | hour | | Week 4 | | | | ID | Title | Description |
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| OG000 | AZD6140 45 mg bd in Japanese Patients | AZD6140 45 mg twice daily in Japanese Patients | | OG001 | AZD6140 45 mg bd in Non-Japanese Patients | AZD6140 45 mg twice daily in non-Japanese patients | | OG002 | AZD6140 90 mg bd in Japanese Patients | AZD6140 90 mg twice daily in Japanese Patients | | OG003 | AZD6140 90 mg bd in Non-Japanese Patients | AZD6140 90 mg twice daily in non-Japanese patients |
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