Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
40-65 years
Phase:
PHASE1
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 investig...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT02278302
Start Date
August 1 1999
Last Update
October 30 2014
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