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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
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
Time frame: up to day 11
Change in general condition rated on 4-point scales
Time frame: up to day 11
Change in motor coordination by means of psychomotor test (2HAND)
Time frame: up to day 11
Change in reaction under stress by means of psychomotor test (DT)
Time frame: up to day 11
Change in vigilance by means of psychomotor test (VIGIL)
Time frame: up to day 11
Change in concentration by means of psychomotor test (SIGNAL)
Time frame: up to day 11
Change in precision and visual orientation by means of psychomotor test (TAVT33)
Time frame: up to day 11
Number of subjects with adverse events
Time frame: up to 25 days
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to day 11
Number of subjects with abnormal changes in vital parameters
Blood Pressure, Pulse Rate, Body temperature
Time frame: up to day 11
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