HealthyPhase 1NCT02268773
Effects of Acetylsalicylic Acid Compared With the Combination of Acetylsalicylic Acid + Modified-release Dipyridamole on Serum Thromboxane B2 Formation and Platelet Aggregation in Healthy Volunteers
A Phase 1 study testing Asasantin®, Acetylsalicylic acid low dose and Acetylsalicylic acid high dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To compare the combination of acetylsalicylic acid (25 mg) + modified-release dipyridamole (200 mg) bd versus acetylsalicylic acid (75 mg dispersible tablet once daily) in its effect on inhibition of thromboxane B2 formation Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Asasantin®, Acetylsalicylic acid low dose and Acetylsalicylic acid high dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to May 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female healthy volunteers aged 20 to 50 years
- Clinically normal medical history
- Clinically normal findings on physical examination
- Capable of comprehending and communicating effectively with the investigator and staff and of providing informed consent
- Willing to give informed consent prior to participation in the trial (i.e. prior to any trial-specific procedures)
Who cannot join
- Any clinically significant disease. (A significant disease is defined as a disease which in the opinion of the investigator may either put the subject at risk because of participation in the study or a disease which may influence the results of the study or the subject's ability to participate in the study)
- Clinically significant abnormal baseline haematology, blood chemistry or urinalysis findings
- Serum glutamate-oxaloacetate transferase (SGOT) or serum glutamate-pyruvate transferase (SGPT) > 80 IU/L, bilirubin > 34 µmol/L or creatinine > 176 µmol/L regardless of clinical condition. Repeat laboratory evaluation will not be conducted in these subjects
- Use of dipyridamole, aspirin or any non-steroidal anti-inflammatory agent (NSAID) during the previous two weeks
- Active peptic ulceration or history of peptic ulcer disease
- Known history of or suspected hypersensitivity to dipyridamole, aspirin, any NSAID or any other component of the test drugs
Show all 16Show fewer
- History of any bleeding disorders
- History of cerebral haemorrhage
- Resting, seated blood pressure less than 90/60 mmHg
- Participation in any drug clinical trial within sixteen weeks prior to the start of the trial
- Any indication of current or previous abuse of alcohol, solvents or drugs
- Any chronic illness
- Asthma
- Requirement for any other medication one month before or during the study
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g. oral contraceptives, intrauterine devices or surgically sterile) were to be excluded
- Previous participation in the randomisation phase of this clinical trial
About this study
Official title: A Randomised, Two-period, Cross-over Trial to Compare the Effects of Acetylsalicylic Acid (75 mg/Day) With the Combination of Acetylsalicylic Acid (25 mg) + Modified-release Dipyridamole (200 mg) (bd) on Serum Thromboxane B2 Formation and Platelet Aggregation in Healthy Volunteers
To compare the combination of acetylsalicylic acid (25 mg) + modified-release dipyridamole (200 mg) bd versus acetylsalicylic acid (75 mg dispersible tablet once daily) in its effect on inhibition of thromboxane B2 formation
- Conditions
- Healthy
- Being tested
- Asasantin®, Acetylsalicylic acid low dose, Acetylsalicylic acid high dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asasantin®Drug
Also called modified-release dipyridamole
Acetylsalicylic acid low doseDrug
Acetylsalicylic acid high doseDrug
| Study group | Role | What they receive |
|---|---|---|
| Acetylsalicylic acid low dose with Asasantin® | Experimental | Not described Receives: Drug: Asasantin®; Drug: Acetylsalicylic acid low dose |
| Acetylsalicylic acid high dose | Active comparator | Not described Receives: Drug: Acetylsalicylic acid high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute serum thromboxane B2 level
Measured: At day 3 after start of drug administration
Secondary outcomes (8)
Change in platelet aggregation
measured ex-vivo
Measured: At day 3 after start of drug administration
Change in time course of inhibition of serum thromboxane B2
Measured: Pre-dose, up to day 14 after start of drug administration
Change in time course of inhibition of platelet aggregation
Measured: Pre-dose, up to day 14 after start of drug administration
Changes from baseline in vital signs
systolic and diastolic blood pressure, pulse rate
Measured: Pre-dose, up to 14 days after first drug administration
Changes from baseline in laboratory tests
Measured: Pre-dose, up to 14 days after first drug administration
Changes from baseline in physical examination
Measured: Pre-dose, up to 14 days after first drug administration
Changes from baseline in 12-lead ECG
Measured: Pre-dose, up to 14 days after first drug administration
Number of patients with adverse events
Measured: Up to 14 days after start of drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startJan 2000
- Primary completionMay 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 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
- NCT02268773
- Sponsor's protocol ID
- 9.130
- Status last verified
- Oct 2014
- First submitted
- 17 Oct 2014
- Last updated
- 20 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Two-period, Cross-over Trial to Compare the Effects of Acetylsalicylic Acid (75 mg/Day) With the Combination of Acetylsalicylic Acid (25 mg) + Modified-release Dipyridamole (200 mg) (bd) on Serum Thromboxane B2 Formation and Platelet Aggregation in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02268773
- Acronym / sponsor ID
- 9.130
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2000
- Primary completion
- May 2000 (actual)
- First posted
- 20 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.
To compare the combination of acetylsalicylic acid (25 mg) + modified-release dipyridamole (200 mg) bd versus acetylsalicylic acid (75 mg dispersible tablet once daily) in its effect on inhibition of thromboxane B2 formation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetylsalicylic acid low dose with Asasantin® | Experimental | Drug: Asasantin®, Drug: Acetylsalicylic acid low dose |
| Acetylsalicylic acid high dose | Active comparator | Drug: Acetylsalicylic acid high dose |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female healthy volunteers aged 20 to 50 years
- Clinically normal medical history
- Clinically normal findings on physical examination
- Capable of comprehending and communicating effectively with the investigator and staff and of providing informed consent
- Willing to give informed consent prior to participation in the trial (i.e. prior to any trial-specific procedures)
Key exclusion criteria (16 listed)
- Any clinically significant disease. (A significant disease is defined as a disease which in the opinion of the investigator may either put the subject at risk because of participation in the study or a disease which may influence the results of the study or the subject's ability to participate in the study)
- Clinically significant abnormal baseline haematology, blood chemistry or urinalysis findings
- Serum glutamate-oxaloacetate transferase (SGOT) or serum glutamate-pyruvate transferase (SGPT) > 80 IU/L, bilirubin > 34 µmol/L or creatinine > 176 µmol/L regardless of clinical condition. Repeat laboratory evaluation will not be conducted in these subjects
- Use of dipyridamole, aspirin or any non-steroidal anti-inflammatory agent (NSAID) during the previous two weeks
- Active peptic ulceration or history of peptic ulcer disease
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 |
|---|---|---|
| Asasantin®Also: modified-release dipyridamole | Drug | Acetylsalicylic acid low dose with Asasantin® |
| Acetylsalicylic acid low dose | Drug | Acetylsalicylic acid low dose with Asasantin® |
| Acetylsalicylic acid high dose | Drug | Acetylsalicylic acid high dose |
Primary outcome
Absolute serum thromboxane B2 level
Time frame: At day 3 after start of drug administration
8 secondary outcomes
Change in platelet aggregation
Time frame: At day 3 after start of drug administration
Change in time course of inhibition of serum thromboxane B2
Time frame: Pre-dose, up to day 14 after start of drug administration
Change in time course of inhibition of platelet aggregation
Time frame: Pre-dose, up to day 14 after start of drug administration
Changes from baseline in vital signs
Time frame: Pre-dose, up to 14 days after first drug administration
Changes from baseline in laboratory tests
Time frame: Pre-dose, up to 14 days after first drug administration
Changes from baseline in physical examination
Time frame: Pre-dose, up to 14 days after first drug administration
Changes from baseline in 12-lead ECG
Time frame: Pre-dose, up to 14 days after first drug administration
Number of patients with adverse events
Time frame: Up to 14 days after start of drug administration
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 20 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 Asasantin®, Acetylsalicylic acid low dose and Acetylsalicylic acid high dose 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 16 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 20 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. 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?
Absolute serum thromboxane B2 level (time frame: At day 3 after start of drug administration). 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 20 Oct 2014.