Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study to investigate whether psychomotor performance which is necessary for safety driving a car or operating machinery and safely participating in daily life is changed by Aggrenox®. Also to investigate whether Aggrenox® impairs performance in combination with alcohol more than alcohol alone. Derived from this: Statement on whether a warning for drivers is necessary
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aggrenox® | Experimental | treatment alone or in combination with Ethanol |
|
| Placebo | Placebo Comparator | treatment alone or in combination with Ethanol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aggrenox® | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in safety relevant performance in the steady state represented and scored by five psychomotor tests | motor coordination, reaction under stress, concentration, vigilance, precision and visual orientation | up to day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in general condition rated on 4-point scales | up to day 11 | |
| Change in motor coordination by means of psychomotor test (2HAND) | up to day 11 | |
| Change in reaction under stress by means of psychomotor test (DT) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Acute disease at the beginning of the study
Any chronic disease in particular:
Women while pregnant or breastfeeding
Women of childbearing age without safe contraception
Psychotropic drugs during the last four weeks before the beginning of and during the study
taking other medicaments regularly during the last two weeks before the beginning of and during the study (except for oral contraceptives, hormone replacement in women)
Body weight outside the Body-Mass-Index (BMI) +- 4
Habits of life style having a presumable negative effect on the results of the performance test (e.g. shift work, extreme sports, blood donation within the last 4 weeks, > 8 cups/glasses of caffeine-containing beverages/day, > 40 g alcohol/day, >40 cigarettes/day)
positive or no drug screening for barbiturates, benzodiazepines, tricyclic antidepressants and cannabinoids, amphetamines, cocaine, opiates
Persons having been detained in an institution by judicial or official order
Persons incapacitated or placed under provisional guardianship
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Ethanol | Other |
|
| up to day 11 |
| Change in vigilance by means of psychomotor test (VIGIL) | up to day 11 |
| Change in concentration by means of psychomotor test (SIGNAL) | up to day 11 |
| Change in precision and visual orientation by means of psychomotor test (TAVT33) | up to day 11 |
| Number of subjects with adverse events | up to 25 days |
| Number of subjects with abnormal changes in laboratory parameters | up to day 11 |
| Number of subjects with abnormal changes in vital parameters | Blood Pressure, Pulse Rate, Body temperature | up to day 11 |
| ID | Term |
|---|---|
| D000068342 | Aspirin, Dipyridamole Drug Combination |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D001241 | Aspirin |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004176 | Dipyridamole |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D000438 | Alcohols |
Not provided
Not provided