Bleeding Time Study With AZD6482, Clopidogrel and ASA | NCT00853450

Studies
Bleeding Time Study With AZD6482, Clopidogrel and ASA

NCT00853450

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Aug 19, 2009Estimated

Enrollment

28Estimated

Phase

Phase 1

Conditions

Antiplatelet Effect

Interventions

AZD6482
Clopidogrel
ASA

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT no. 2008-007030-21

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Not provided

Completion Date

Jul 2009Actual

First Submitted Date

Feb 27, 2009

First Submission Date that Met QC Criteria

Feb 27, 2009

First Posted Date

Mar 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2009

Last Update Posted Date

Aug 19, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	AZD6482 on top of ASA	Drug: AZD6482 Drug: ASA
2	Active Comparator	Clopidogrel on top of ASA	Drug: Clopidogrel Drug: ASA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD6482	Drug	Single intravenous infusion during a maximum of 5 hours	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Pharmacokinetics		Prior to AZD6482 infusion and repeatedly during 6 hours after end of infusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Held	AstraZeneca Mölndal	Study Director
Bo Fransson, MD	AstraZeneca Clinical Pharmacology Unit, Lund	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Lund			Sweden

Intervention Browse Module

MeSH Terms

ID	Term
C578518	2-(1-(7-methyl-2-morpholin-4-yl-4-oxo-4H-pyrido(1,2-a)pyrimidin-9-yl)ethylamino)benzoic acid
D000077144	Clopidogrel

Ancestor Terms

ID	Term
D013988	Ticlopidine
D058924	Thienopyridines
D013876	Thiophenes
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided