NCT01603342

A Pilot Study to Determine the Impact of Clopidogrel (Plavix®) on Bleeding Associated With Punch Biopsies in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Haemostasis
• Healthy

Interventions

Type	Name	Description
DRUG	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
DRUG	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

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2012-05-22
• Last updated: 2016-11-25

Locations

1 site across 1 country: United States