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

NCT ID: NCT02278302

Last Updated: 2014-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-08-31

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Aggrenox®

treatment alone or in combination with Ethanol

Group Type: EXPERIMENTAL

Aggrenox®

Intervention Type: DRUG

Ethanol

Intervention Type: OTHER

Placebo

treatment alone or in combination with Ethanol

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Ethanol

Intervention Type: OTHER

Interventions

Aggrenox®

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Ethanol

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

9.135

Identifier Type: -

Identifier Source: org_study_id