Bleeding Time Study With AZD6482, Clopidogrel and ASA
- Registration Number
- NCT00853450
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 28
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 ASA AZD6482 on top of ASA 1 AZD6482 AZD6482 on top of ASA 2 Clopidogrel Clopidogrel on top of ASA 2 ASA Clopidogrel on top of ASA
- Primary Outcome Measures
Name Time Method Capillary Bleeding Time (CBT) 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 Outcome Measures
Name Time Method Effect on bleeding 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 Prior to AZD6482 infusion and repeatedly during 6 hours after end of infusion Safety variables (adverse events, blood pressure, pulse, ECG, safety lab) Repeatedly during the study
Trial Locations
- Locations (1)
Research Site
🇸🇪Lund, Sweden