Bleeding time study with AZD6482, Clopidogrel and ASA
Study identifier:D1700C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Antiplatelet effect
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD6482, Clopidogrel, ASA
Sex
Male
Actual Enrollment
28
Study type
Interventional
Age
18 Years - 50 Years
Date
Study Start Date: 01 Feb 2009
Primary Completion Date: -
Study Completion Date: 01 Jul 2009
Study design
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD6482 on top of ASA | Drug: AZD6482 Single intravenous infusion during a maximum of 5 hours Drug: ASA 75 mg orally once daily during 7 days in each treatment arm Other Name: Trombyl® |
| Active Comparator: 2 Clopidogrel on top of ASA | Drug: Clopidogrel Oral doses given once daily during 7 days. 300 mg on day 1 and 75 mg on day 2 to 7. Other Name: Plavix® Drug: ASA 75 mg orally once daily during 7 days in each treatment arm Other Name: Trombyl® |
Contacts
Investigators
Principal Investigator
Peter Held
AstraZeneca Mölndal
