Study to Compare the Effect of a Combination of Dipyridamole With Sustained Release and Acetyl Salicylic Acid (Aggrenox®) on the Performance Relevant to Safety and on the General Condition of Healthy Volunteers

Study Overview
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Brief Summary
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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

Official Title
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Placebo-controlled, Randomized, Double-blind Study Comparing the Effect of a Combination of 200 mg Dipyridamole With Sustained Release and 25 mg Acetyl Salicylic Acid (Aggrenox®) on the Performance Relevant to Safety and on the General Condition of Volunteers and 10 Days of Treatment Alone and in Combination With Alcohol (Study no. 591002)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Aggrenox®
* Drug: Placebo
* Other: Ethanol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aggrenox®<br>treatment alone or in combination with Ethanol | Drug: Aggrenox®<br> <br> Other: Ethanol<br> <br> |
| Placebo Comparator: Placebo<br>treatment alone or in combination with Ethanol | Drug: Placebo<br> <br> Other: Ethanol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 |