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Completed

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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Key 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

Aggrenox®

Drug

Placebo

Drug

Ethanol

Other

Primary outcomes

  1. 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

  1. Change in general condition rated on 4-point scales

    Time frame: up to day 11

  2. Change in motor coordination by means of psychomotor test (2HAND)

    Time frame: up to day 11

  3. Change in reaction under stress by means of psychomotor test (DT)

    Time frame: up to day 11

  4. Change in vigilance by means of psychomotor test (VIGIL)

    Time frame: up to day 11

  5. Change in concentration by means of psychomotor test (SIGNAL)

    Time frame: up to day 11

  6. Change in precision and visual orientation by means of psychomotor test (TAVT33)

    Time frame: up to day 11

  7. Number of subjects with adverse events

    Time frame: up to 25 days

  8. Number of subjects with abnormal changes in laboratory parameters

    Time frame: up to day 11

  9. 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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