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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Aggrenox®; Drug: Placebo; Other: Ethanol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02278302

9.135

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

Aggrenox®

Experimental group

Description:

treatment alone or in combination with Ethanol

Treatment:

Drug: Aggrenox®

Other: Ethanol

Placebo

Placebo Comparator group

Description:

treatment alone or in combination with Ethanol

Treatment:

Other: Ethanol

Drug: Placebo