Clinical trial NCT02278302: 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
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-30
Enrollment: 56
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change in safety relevant performance in the steady state represented and scored by five psychomotor tests
timeFrame: up to day 11
Secondary outcomes:
measure: Change in general condition rated on 4-point scales
timeFrame: up to day 11
measure: Change in motor coordination by means of psychomotor test (2HAND)
timeFrame: up to day 11
measure: Change in reaction under stress by means of psychomotor test (DT)
timeFrame: up to day 11
measure: Change in vigilance by means of psychomotor test (VIGIL)
timeFrame: up to day 11
measure: Change in concentration by means of psychomotor test (SIGNAL)
timeFrame: up to day 11
measure: Change in precision and visual orientation by means of psychomotor test (TAVT33)
timeFrame: up to day 11
measure: Number of subjects with adverse events
timeFrame: up to 25 days
measure: Number of subjects with abnormal changes in laboratory parameters
timeFrame: up to day 11
measure: Number of subjects with abnormal changes in vital parameters
timeFrame: up to day 11
Other outcomes:
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