Bleeding Time Study With AZD6482, Clopidogrel and ASA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Antiplatelet Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

AZD6482 on top of ASA

Group Type EXPERIMENTAL

AZD6482

Intervention Type DRUG

Single intravenous infusion during a maximum of 5 hours

ASA

Intervention Type DRUG

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

2

Clopidogrel on top of ASA

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

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

ASA

Intervention Type DRUG

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

Interventions

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AZD6482

Single intravenous infusion during a maximum of 5 hours

Intervention Type DRUG

Clopidogrel

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

Intervention Type DRUG

ASA

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

Intervention Type DRUG

Other Intervention Names

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Plavix® Trombyl®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes