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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Aspirin; Aspirin, Dipyridamole Drug Combination; Dipyridamole; Ethanol; Salicylates; Salicylic Acid

Criteria

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