Healthy
Conditions
Brief summary
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
Interventions
DRUGAggrenox®
DRUGPlacebo
OTHEREthanol
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Race: Caucasian * Men and women aged between 40 and 65 years * Written and spoken command of German * Ability to understand the nature and significance of the study * Written informed consent to participate in the study
Exclusion criteria
* Acute disease at the beginning of the study * Any chronic disease in particular: * Diseases for which the administration of the test drug was contraindicated: * Severe coronary heart disease (e.g. unstable angina pectoris or recent myocardial infarction) * Subvalvular aortic stenosis or hemodynamic instability, myocardial decompensation * Severe hypotension, hypotonic collapse * Any other cardiac disease (or case history of) * Chronic obstructive lung disease * Hepatic and renal dysfunction * Diseases of the gastrointestinal tract * Mental or neurologic diseases * Alcoholism, alcohol abuse * Case history of clinically relevant allergies (particularly against one of the ingredients of the test substance incl. paracetamol) * Participation in another clinical study during the last two months preceding the study * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in safety relevant performance in the steady state represented and scored by five psychomotor tests | up to day 11 | motor coordination, reaction under stress, concentration, vigilance, precision and visual orientation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events | up to 25 days | — |
| 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) | up to day 11 | — |
| Change in precision and visual orientation by means of psychomotor test (TAVT33) | up to day 11 | — |
| Change in concentration by means of psychomotor test (SIGNAL) | up to day 11 | — |
| Number of subjects with abnormal changes in laboratory parameters | up to day 11 | — |
| Number of subjects with abnormal changes in vital parameters | up to day 11 | Blood Pressure, Pulse Rate, Body temperature |
| Change in vigilance by means of psychomotor test (VIGIL) | up to day 11 | — |
Outcome results
None listed