- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01603342
A Pilot Study to Determine the Impact of Clopidogrel (Plavix®) on Bleeding Associated With Punch Biopsies in Healthy Volunteers
November 23, 2016 updated by: Novo Nordisk A/S
This trial is conducted in the United States of America (USA).
The aim of this trial is to determine the feasibility of demonstrating a quantifiable change from baseline in punch biopsy-induced bleeding durations and blood loss volumes in healthy subjects after receiving clopidogrel anti-platelet therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Neptune, New Jersey, United States, 07753
- Novo Nordisk INvestigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- PT within normal laboratory range
Exclusion Criteria:
- The receipt of any investigational drug within 1 month prior to this trial
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 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
|
Experimental: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bleeding duration measured in minutes
Time Frame: From onset of bleeding till the end of the bleeding
|
From onset of bleeding till the end of the bleeding
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood volume reported in millilitres
Time Frame: From onset of bleeding till the end of the bleeding
|
From onset of bleeding till the end of the bleeding
|
Adverse events, including special attention to bleeding complications
Time Frame: From day 0 to days 11-17
|
From day 0 to days 11-17
|
Change in coagulation-related parameters
Time Frame: From baseline to 15 minutes after biopsy B1
|
From baseline to 15 minutes after biopsy B1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
May 16, 2012
First Submitted That Met QC Criteria
May 21, 2012
First Posted (Estimate)
May 22, 2012
Study Record Updates
Last Update Posted (Estimate)
November 25, 2016
Last Update Submitted That Met QC Criteria
November 23, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F7HAEM-1954
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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