Bleeding Time Study With AZD6482, Clopidogrel and ASA

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00853450
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 ClinicalTrials.gov 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
Interventional
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
    Interventions:
    • Drug: AZD6482
    • Drug: ASA
  • Active Comparator: 2
    Clopidogrel on top of ASA
    Interventions:
    • Drug: Clopidogrel
    • Drug: ASA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
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
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00853450
D1700C00004, EudraCT no. 2008-007030-21
No
Peter Held, Medical Science Director, Early Thrombosis & Haemostasis, AstraZeneca
AstraZeneca
Not Provided
Study Director: Peter Held AstraZeneca Mölndal
Principal Investigator: Bo Fransson, MD AstraZeneca Clinical Pharmacology Unit, Lund
AstraZeneca
August 2009

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