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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Aggrenox®; Drug: Placebo; Other: Ethanol

• Registration Number: NCT02278302
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-08
• Primary Completion: 2000-03
• Status Verified: 2014-10
• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2014-10-28
• Last Update Submitted: 2014-10-28
• Study First Posted: 2014-10-30
• Last Update Posted: 2014-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aggrenox®	Ethanol	treatment alone or in combination with Ethanol
Placebo	Ethanol	treatment alone or in combination with Ethanol
Aggrenox®	Aggrenox®	treatment alone or in combination with Ethanol
Placebo	Placebo	treatment alone or in combination with Ethanol

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in vigilance by means of psychomotor test (VIGIL)	up to day 11
Change in general condition rated on 4-point scales	up to day 11
Change in concentration by means of psychomotor test (SIGNAL)	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
Change in precision and visual orientation by means of psychomotor test (TAVT33)	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
Number of subjects with abnormal changes in vital parameters	up to day 11	Blood Pressure, Pulse Rate, Body temperature