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

NCT02278302 | Completed Phase 1

• 1 other identifier: 9.135
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

Aggrenox®

EXPERIMENTAL

treatment alone or in combination with Ethanol

Drug: Aggrenox®; Other: Ethanol

Placebo

PLACEBO COMPARATOR

treatment alone or in combination with Ethanol

Drug: Placebo; Other: Ethanol

Interventions

Aggrenox® DRUG

Aggrenox®

Placebo DRUG

Placebo

Ethanol OTHER

Aggrenox®; Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Aspirin, Dipyridamole Drug Combination; Ethanol

Intervention Hierarchy (Ancestors)

Aspirin; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Dipyridamole; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Alcohols

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: October 30, 2014
• Study Start: August 1, 1999
• Primary Completion: March 1, 2000
• Last Updated: October 30, 2014

Record last verified: 2014-10