HealthyPhase 1NCT02278302
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
A Phase 1 study testing Aggrenox® and Ethanol in people with Healthy, run by Boehringer Ingelheim.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Aggrenox® and Ethanol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Aug 1999to Mar 2000
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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 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
- Being tested
- Aggrenox®, Placebo, Ethanol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aggrenox®Drug
PlaceboDrug
EthanolOther
| Study group | Role | What they receive |
|---|---|---|
| Aggrenox® | Experimental | treatment alone or in combination with Ethanol Receives: Drug: Aggrenox®; Other: Ethanol |
| Placebo | Placebo comparator | treatment alone or in combination with Ethanol Receives: Drug: Placebo; Other: Ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to day 11
Secondary outcomes (9)
Change in general condition rated on 4-point scales
Measured: up to day 11
Change in motor coordination by means of psychomotor test (2HAND)
Measured: up to day 11
Change in reaction under stress by means of psychomotor test (DT)
Measured: up to day 11
Change in vigilance by means of psychomotor test (VIGIL)
Measured: up to day 11
Change in concentration by means of psychomotor test (SIGNAL)
Measured: up to day 11
Change in precision and visual orientation by means of psychomotor test (TAVT33)
Measured: up to day 11
Number of subjects with adverse events
Measured: up to 25 days
Number of subjects with abnormal changes in laboratory parameters
Measured: up to day 11
Number of subjects with abnormal changes in vital parameters
Blood Pressure, Pulse Rate, Body temperature
Measured: up to day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startAug 1999
- Primary completionMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278302
- Sponsor's protocol ID
- 9.135
- Status last verified
- Oct 2014
- First submitted
- 28 Oct 2014
- Last updated
- 30 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02278302
- Acronym / sponsor ID
- 9.135
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 1999
- Primary completion
- Mar 2000 (actual)
- First posted
- 30 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aggrenox® | Experimental | Drug: Aggrenox®, Other: Ethanoltreatment alone or in combination with Ethanol |
| Placebo | Placebo comparator | Drug: Placebo, Other: Ethanoltreatment alone or in combination with Ethanol |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (23 listed)
- Acute disease at the beginning of the study
- Any chronic disease in particular:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aggrenox® | Drug | Aggrenox® |
| Placebo | Drug | Placebo |
| Ethanol | Other | Aggrenox®, Placebo |
Primary outcome
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
9 secondary outcomes
Change in general condition rated on 4-point scales
Time frame: up to day 11
Change in motor coordination by means of psychomotor test (2HAND)
Time frame: up to day 11
Change in reaction under stress by means of psychomotor test (DT)
Time frame: up to day 11
Change in vigilance by means of psychomotor test (VIGIL)
Time frame: up to day 11
Change in concentration by means of psychomotor test (SIGNAL)
Time frame: up to day 11
Change in precision and visual orientation by means of psychomotor test (TAVT33)
Time frame: up to day 11
Number of subjects with adverse events
Time frame: up to 25 days
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to day 11
Number of subjects with abnormal changes in vital parameters
Time frame: up to day 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aggrenox® and Ethanol in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in safety relevant performance in the steady state represented and scored by five psychomotor tests (time frame: up to day 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2014.