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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

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ClinicalTrials.gov Identifier: NCT02278302
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Healthy Drug: Aggrenox® Drug: Placebo Other: Ethanol Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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)
Study Start Date : August 1999
Actual Primary Completion Date : March 2000

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02278302    
Other Study ID Numbers: 9.135
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: October 30, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Aspirin
Ethanol
Salicylic Acid
Salicylates
Dipyridamole
Aspirin, Dipyridamole Drug Combination
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Fibrinolytic Agents
Fibrin Modulating Agents
Antipyretics