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Bleeding Time Study With AZD6482, Clopidogrel and ASA

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00853450
Collaborator
(none)
28
Enrollment
1
Location
2
Arms
4.9
Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Feb 1, 2009
Actual Study Completion Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Plavix®

    • Drug: ASA
    75 mg orally once daily during 7 days in each treatment arm
    Other Names:
  • Trombyl®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    2. Pharmacokinetics [Prior to AZD6482 infusion and repeatedly during 6 hours after end of infusion]

    3. Safety variables (adverse events, blood pressure, pulse, ECG, safety lab) [Repeatedly during the study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Lund Sweden

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Peter Held, AstraZeneca Mölndal
    • Principal Investigator: Bo Fransson, MD, AstraZeneca Clinical Pharmacology Unit, Lund

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00853450
    Other Study ID Numbers:
    • D1700C00004
    • EudraCT no. 2008-007030-21
    First Posted:
    Mar 2, 2009
    Last Update Posted:
    Aug 19, 2009
    Last Verified:
    Aug 1, 2009
    Keywords provided by , ,
    Antiplatelet
    Additional relevant MeSH terms:
    Hemorrhage
    Clopidogrel

    Study Results

    No Results Posted as of Aug 19, 2009