Antiplatelet EffectPhase 1NCT00853450
Bleeding Time Study With AZD6482, Clopidogrel and ASA
A Phase 1 study testing AZD6482, Clopidogrel and ASA in people with Antiplatelet Effect, run by AstraZeneca at 1 site in Sweden.
Trial summary
The primary purpose of this study is to evaluate the effect of AZD6482 and clopidogrel on bleeding time when taken together with low-dose ASA. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Antiplatelet Effect
- What is being tested?
- AZD6482, Clopidogrel and ASA
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2009to Jul 2009
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive
- Provision of written informed consent
Who cannot join
- Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms.
- Acute illness, surgical procedure or trauma from 2 weeks before pre-entry visit until the first baseline visit or clinically significant abnormalities in clinical chemistry, haematology, urinalysis or supine BP or pulse
- Known impaired glucose tolerance, known galactose intolerance, total lactase deficiency or glucose-galactose malabsorption or known or suspected Gilbert's syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Open-label, Single-Centre, Phase I, Crossover Study to Evaluate the Effect of AZD6482, Compared With Clopidogrel, on Bleeding Time in Healthy Volunteers Receiving Low-Dose ASA
The primary purpose of this study is to evaluate the effect of AZD6482 and clopidogrel on bleeding time when taken together with low-dose ASA.
- Conditions
- Antiplatelet Effect
- Being tested
- AZD6482, Clopidogrel, ASA
- Keywords
- Antiplatelet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6482Drug
Single intravenous infusion during a maximum of 5 hours
ClopidogrelDrug
Also called Plavix®
Oral doses given once daily during 7 days. 300 mg on day 1 and 75 mg on day 2 to 7.
ASADrug
Also called Trombyl®
75 mg orally once daily during 7 days in each treatment arm
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD6482 on top of ASA Receives: Drug: AZD6482; Drug: ASA |
| 2 | Active comparator | Clopidogrel on top of ASA Receives: Drug: Clopidogrel; Drug: ASA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary Bleeding Time (CBT)
Measured: Prior to first dose in each treatment period, on study day 6 and 7 in treatment period A and on study day 7 in treatment period B
Secondary outcomes (3)
Effect on bleeding
Measured: Prior to first dose in each treatment period, twice on study day 6 and three times on study day 7 in treatment period A and twice on study day 7 in treatment period B
Pharmacokinetics
Measured: Prior to AZD6482 infusion and repeatedly during 6 hours after end of infusion
Safety variables (adverse events, blood pressure, pulse, ECG, safety lab)
Measured: Repeatedly during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startFeb 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiplatelet EffectStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Held, Study director, AstraZeneca MölndalBo Fransson, MD, Principal investigator, AstraZeneca Clinical Pharmacology Unit, Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853450
- Sponsor's protocol ID
- D1700C00004
- Other IDs
- EudraCT no. 2008-007030-21
- Status last verified
- Aug 2009
- First submitted
- 27 Feb 2009
- Last updated
- 19 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-label, Single-Centre, Phase I, Crossover Study to Evaluate the Effect of AZD6482, Compared With Clopidogrel, on Bleeding Time in Healthy Volunteers Receiving Low-Dose ASA
- ClinicalTrials.gov ID
- NCT00853450
- Acronym / sponsor ID
- D1700C00004
- Conditions
- Antiplatelet Effect
- Keywords
- Antiplatelet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Study completion
- Jul 2009 (actual)
- First posted
- 2 Mar 2009 (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.
The primary purpose of this study is to evaluate the effect of AZD6482 and clopidogrel on bleeding time when taken together with low-dose ASA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD6482, Drug: ASAAZD6482 on top of ASA |
| 2 | Active comparator | Drug: Clopidogrel, Drug: ASAClopidogrel on top of ASA |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive
- Provision of written informed consent
Key exclusion criteria (3 listed)
- Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms.
- Acute illness, surgical procedure or trauma from 2 weeks before pre-entry visit until the first baseline visit or clinically significant abnormalities in clinical chemistry, haematology, urinalysis or supine BP or pulse
- Known impaired glucose tolerance, known galactose intolerance, total lactase deficiency or glucose-galactose malabsorption or known or suspected Gilbert's syndrome
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 |
|---|---|---|
| AZD6482Single intravenous infusion during a maximum of 5 hours | Drug | 1 |
| ClopidogrelAlso: Plavix®Oral doses given once daily during 7 days. 300 mg on day 1 and 75 mg on day 2 to 7. | Drug | 2 |
| ASAAlso: Trombyl®75 mg orally once daily during 7 days in each treatment arm | Drug | 1, 2 |
Primary outcome
Capillary Bleeding Time (CBT)
Time frame: Prior to first dose in each treatment period, on study day 6 and 7 in treatment period A and on study day 7 in treatment period B
3 secondary outcomes
Effect on bleeding
Time frame: Prior to first dose in each treatment period, twice on study day 6 and three times on study day 7 in treatment period A and twice on study day 7 in treatment period B
Pharmacokinetics
Time frame: Prior to AZD6482 infusion and repeatedly during 6 hours after end of infusion
Safety variables (adverse events, blood pressure, pulse, ECG, safety lab)
Time frame: Repeatedly during the study
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 19 Aug 2009.
Related trials for Antiplatelet Effect
Recruiting
Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)
Coronary Disease, Heart Diseases
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.
Peter Held study director
AstraZeneca Mölndal
Bo Fransson, MD principal investigator
AstraZeneca Clinical Pharmacology Unit, Lund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD6482, Clopidogrel and ASA in people with Antiplatelet Effect, run by AstraZeneca at 1 site in Sweden.
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 2 inclusion and 3 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 19 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Capillary Bleeding Time (CBT) (time frame: Prior to first dose in each treatment period, on study day 6 and 7 in treatment period A and on study day 7 in treatment period B). 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 19 Aug 2009; AzTrials last refreshed its copy on 28 Oct 2026.