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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
History of Changes
  Purpose

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 Intervention Phase
Antiplatelet Effect
 Drug: AZD6482
Drug: Clopidogrel
Drug: ASA
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 28
Study Start Date: February 2009
Study Completion Date: July 2009
Arms Assigned Interventions
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 Name: 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 Name: Plavix®
Drug: ASA
75 mg orally once daily during 7 days in each treatment arm
Other Name: Trombyl®

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853450

Locations
Sweden
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
  More Information

No publications provided

Responsible Party: Peter Held, Medical Science Director, Early Thrombosis & Haemostasis, AstraZeneca
ClinicalTrials.gov Identifier: NCT00853450     History of Changes
Other Study ID Numbers: D1700C00004, EudraCT no. 2008-007030-21
Study First Received: February 27, 2009
Last Updated: August 18, 2009
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
Antiplatelet

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
 Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013