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CompletedNCT00853450Updated Aug 19, 2009

Bleeding Time Study With AZD6482, Clopidogrel and ASA

A Phase 1 interventional study of AZD6482 and Clopidogrel in Antiplatelet Effect, sponsored by AstraZeneca. Completed at 1 site in Sweden. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-08-19.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Antiplatelet Effect

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Keywords

  • Antiplatelet
03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's planned enrollment of 28 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    1

    AZD6482 on top of ASA

    Drug: AZD6482 · Drug: ASA

  • Active comparator
    2

    Clopidogrel on top of ASA

    Drug: Clopidogrel · Drug: ASA

Interventions

  • DrugAZD6482

    Single intravenous infusion during a maximum of 5 hours

  • DrugClopidogrel

    Oral doses given once daily during 7 days. 300 mg on day 1 and 75 mg on day 2 to 7.

    Also known as: Plavix®

  • DrugASA

    75 mg orally once daily during 7 days in each treatment arm

    Also known as: Trombyl®

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Pharmacokinetics

    Time frame: Prior to AZD6482 infusion and repeatedly during 6 hours after end of infusion

  3. Safety variables (adverse events, blood pressure, pulse, ECG, safety lab)

    Time frame: Repeatedly during the study

07

Study locations

1 site
  • Research Site
    Lund, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00853450
Lead sponsor
AstraZeneca
First posted
Mar 2, 2009
Start date
Feb 2009
Completion
Jul 2009
Last update
Aug 19, 2009

Study contacts

Peter Held
study director · AstraZeneca Mölndal
Bo Fransson, MD
principal investigator · AstraZeneca Clinical Pharmacology Unit, Lund

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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