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Bleeding Time Study With AZD6482, Clopidogrel and ASA

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: February 27, 2009
Last updated: August 18, 2009
Last verified: August 2009

February 27, 2009
August 18, 2009
February 2009
Not Provided
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00853450 on Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: Prior to AZD6482 infusion and repeatedly during 6 hours after end of infusion ] [ Designated as safety issue: No ]
  • Safety variables (adverse events, blood pressure, pulse, ECG, safety lab) [ Time Frame: Repeatedly during the study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
Bleeding Time Study With AZD6482, Clopidogrel and ASA
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.

Not Provided
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Antiplatelet Effect
  • Drug: AZD6482
    Single intravenous infusion during a maximum of 5 hours
  • 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®
  • Experimental: 1
    AZD6482 on top of ASA
    • Drug: AZD6482
    • Drug: ASA
  • Active Comparator: 2
    Clopidogrel on top of ASA
    • Drug: Clopidogrel
    • Drug: ASA
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2009
Not Provided

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
18 Years to 50 Years
Contact information is only displayed when the study is recruiting subjects
D1700C00004, EudraCT no. 2008-007030-21
Peter Held, Medical Science Director, Early Thrombosis & Haemostasis, AstraZeneca
Not Provided
Study Director: Peter Held AstraZeneca Mölndal
Principal Investigator: Bo Fransson, MD AstraZeneca Clinical Pharmacology Unit, Lund
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP