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

NCT01603342 | Completed Phase 1

• 1 other identifier: F7HAEM-1954
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Haemostasis; Healthy

Outcome Measures

Primary Outcomes (1)

• Bleeding duration measured in minutes

  From onset of bleeding till the end of the bleeding

Secondary Outcomes (3)

• Blood volume reported in millilitres

  From onset of bleeding till the end of the bleeding

• Adverse events, including special attention to bleeding complications

  From day 0 to days 11-17

• Change in coagulation-related parameters

  From baseline to 15 minutes after biopsy B1

Study Arms (2)

clopidogrel

EXPERIMENTAL

Drug: clopidogrel

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

clopidogrel DRUG

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

clopidogrel

placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PT within normal laboratory range

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neptune City, New Jersey, 07753, United States

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Interventions

Clopidogrel

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2012
• First Posted: May 22, 2012
• Study Start: December 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: November 25, 2016

Record last verified: 2016-11

Locations

US (1)