NCT Number: 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
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
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Notify MeKey information
Conditions
Age range
40 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Placebo
DrugEthanol
OtherPrimary outcomes
-
Change in safety relevant performance in the steady state represented and scored by five psychomotor tests
Time frame: up to day 11
motor coordination, reaction under stress, concentration, vigilance, precision and visual orientation
Secondary outcomes
-
Change in general condition rated on 4-point scales
Time frame: up to day 11
-
Change in motor coordination by means of psychomotor test (2HAND)
Time frame: up to day 11
-
Change in reaction under stress by means of psychomotor test (DT)
Time frame: up to day 11
-
Change in vigilance by means of psychomotor test (VIGIL)
Time frame: up to day 11
-
Change in concentration by means of psychomotor test (SIGNAL)
Time frame: up to day 11
-
Change in precision and visual orientation by means of psychomotor test (TAVT33)
Time frame: up to day 11
-
Number of subjects with adverse events
Time frame: up to 25 days
-
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to day 11
-
Number of subjects with abnormal changes in vital parameters
Time frame: up to day 11
Blood Pressure, Pulse Rate, Body temperature
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study 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)
Important dates
- Study start
- 1999
- Primary completion
- 2000
- First posted
- Oct 30, 2014
- Registry last updated
- Oct 30, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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