A Pilot Study to Determine the Impact of Clopidogrel (Plavix®) on Bleeding Associated With Punch Biopsies in Healthy Volunteers
NCT ID: NCT01603342
Last Updated: 2016-11-25
Study Results
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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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2007-12-31
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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clopidogrel
clopidogrel
Following a baseline punch biopsy, all subjects will then receive oral clopidogrel (Plavix®) over a period of approximately 3 to 4 days. Once the subject has successfully had 3 days of clopidogrel dosing, a second biopsy (B1) will be performed
Placebo
placebo
Following a baseline punch biopsy, all subjects will then receive oral placebo over a period of approximately 3 to 4 days. Once the subject has successfully had 3 days of clopidogrel dosing, a second biopsy will be performed
Interventions
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clopidogrel
Following a baseline punch biopsy, all subjects will then receive oral clopidogrel (Plavix®) over a period of approximately 3 to 4 days. Once the subject has successfully had 3 days of clopidogrel dosing, a second biopsy (B1) will be performed
placebo
Following a baseline punch biopsy, all subjects will then receive oral placebo over a period of approximately 3 to 4 days. Once the subject has successfully had 3 days of clopidogrel dosing, a second biopsy will be performed
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Use of anti-coagulation or anti-platelet therapy-defined as vitamin K antagonists, platelet antagonists, heparin (or low molecular weight heparin), aspirin or NSAIDs within 30 days prior to trial
* African-American race
* Weight above or equal to 160 kg
* Recent diagnosis of any illness that would be present concomitant to trial period
18 Years
MALE
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Neptune City, New Jersey, United States
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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F7HAEM-1954
Identifier Type: -
Identifier Source: org_study_id