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

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 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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Aggrenox®; Other: Ethanol

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aggrenox®; treatment alone or in combination with Ethanol	Drug: Aggrenox®; Other: Ethanol
Placebo Comparator: Placebo; treatment alone or in combination with Ethanol	Drug: Placebo; Other: Ethanol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in safety relevant performance in the steady state represented and scored by five psychomotor tests	motor coordination, reaction under stress, concentration, vigilance, precision and visual orientation	up to day 11

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in general condition rated on 4-point scales		up to day 11
Change in motor coordination by means of psychomotor test (2HAND)		up to day 11
Change in reaction under stress by means of psychomotor test (DT)		up to day 11
Change in vigilance by means of psychomotor test (VIGIL)		up to day 11
Change in concentration by means of psychomotor test (SIGNAL)		up to day 11
Change in precision and visual orientation by means of psychomotor test (TAVT33)		up to day 11
Number of subjects with adverse events		up to 25 days
Number of subjects with abnormal changes in laboratory parameters		up to day 11
Number of subjects with abnormal changes in vital parameters	Blood Pressure, Pulse Rate, Body temperature	up to day 11

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 1999
• Primary Completion (Actual): March 1, 2000

Study Registration Dates

• First Submitted: October 28, 2014
• First Submitted That Met QC Criteria: October 28, 2014
• First Posted (Estimate): October 30, 2014

Study Record Updates

• Last Update Posted (Estimate): October 30, 2014
• Last Update Submitted That Met QC Criteria: October 28, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Platelet Aggregation Inhibitors; Ethanol; Aspirin, Dipyridamole Drug Combination
• Other Study ID Numbers: 9.135