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To investigate the occurrence of dipyridamole associated headaches in healthy subjects using a titration scheme or not
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asasantin ER | Experimental | Administered once daily (days 1 to 7), followed by twice daily administration (days 8 to 14) |
|
| Asasantin ER, administered twice daily from day 1 to day 14 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asasantin ER | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulated headache (intensity x duration) per day based on mean severity per waking hours expressed as area under the curve (AUC) | Day 14 after first drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects experiencing moderate/severe headache | Day 14 after first drug administration | |
| Proportion of subjects experiencing headache | Day 14 after first drug administration | |
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Inclusion Criteria:
Exclusion Criteria:
For female subjects:
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| Drug |
|
| Cumulated headache (intensity x duration) per day based on maximum severity per day expressed as AUC |
| Day 14 after first drug administration |
| Amount of acetylsalicylic acid (ASA) 500 used to cut headache | Day 14 after first drug administration |
| Changes from baseline in vital signs | Pre-dose and day 17 after first drug administration |
| Changes from baseline in laboratory tests | Pre-dose and day 17 after first drug administration |
| Changes from baseline in 12-lead ECG | Pre-dose and day 17 after first drug administration |
| Changes from baseline in physical examination | Pre-dose and day 17 after first drug administration |
| Number of patients with adverse events | Up to day 17 after first drug administration |