Back to resultsA Pilot Study to Determine the Impact of Clopidogrel (Plavix®) on Bleeding Associated With Punch Biopsies in Healthy Volunteers
Primary Purpose
Haemostasis, Healthy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
clopidogrel
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Haemostasis
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
clopidogrel
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Bleeding duration measured in minutes
Secondary Outcome Measures
Blood volume reported in millilitres
Adverse events, including special attention to bleeding complications
Change in coagulation-related parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01603342
Brief Title
A Pilot Study to Determine the Impact of Clopidogrel (Plavix®) on Bleeding Associated With Punch Biopsies in Healthy Volunteers
Official Title
A Pilot Study to Determine the Impact of Clopidogrel (Plavix®) on Bleeding Associated With Punch Biopsies in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemostasis, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
clopidogrel
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Bleeding duration measured in minutes
Time Frame
From onset of bleeding till the end of the bleeding
Secondary Outcome Measure Information:
Title
Blood volume reported in millilitres
Time Frame
From onset of bleeding till the end of the bleeding
Title
Adverse events, including special attention to bleeding complications
Time Frame
From day 0 to days 11-17
Title
Change in coagulation-related parameters
Time Frame
From baseline to 15 minutes after biopsy B1
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Pilot Study to Determine the Impact of Clopidogrel (Plavix®) on Bleeding Associated With Punch Biopsies in Healthy Volunteers
We'll reach out to this number within 24 hrs