NCT00413608

Brief Summary

To test pharmacodynamic response to clopidogrel 150mg once daily during 7 days in healthy subjects carriers of a mutated allele (\*2) associated with CYP2C19 deficiency and non responders to the usual regimen of 75 mg once daily

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2006

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

May 5, 2011

Status Verified

July 1, 2007

Enrollment Period

2 years

First QC Date

December 19, 2006

Last Update Submit

May 4, 2011

Conditions

Healthy

Keywords

HumanAdultsMaleAllelesGenotypePlatelet Aggregation/drug effectsPlatelet Aggregation Inhibitors/*pharmacologyPlatelet Function TestsPharmacogenetics*Polymorphism, GeneticTiclopidine/*analogs & derivatives/pharmacologyHealthy subjects

Outcome Measures

Primary Outcomes (1)

  • Inhibition platelet activity index (ADP induced aggregation) measured between

    during 7 days

Secondary Outcomes (1)

  • Clopidogrel and metabolites pharmacokinetics and relation to dynamics

    during 7 days

Study Arms (2)

1

EXPERIMENTAL

Clopidogrel

Drug: Clopidogrel

2

EXPERIMENTAL

Clopidogrel

Drug: Clopidogrel

Interventions

ClopidogrelDRUG

Clopidogrel

12

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers, aged 18 to 35, non smoker, of caucasian origin
  • Compatible 2C19 and P2Y12 genotypes
  • Weight 60 kg to 100 kg, and normal BMI
  • Standard laboratory investigations normal
  • Negative testing for HIV infection and B and C hepatitis
  • Basal platelet agregation testing normal
  • EKG, blood pressure and cardiac frequency in normal range
  • Ability to understand, follow and sign the protocol

You may not qualify if:

  • Evolutive medical affection, even treated
  • Medical history of allergic response to medication or other, peptic ulcer, or known hemorrhagic disorder
  • Laboratory testing out of normal range
  • Subjects practicing violent sports
  • Unability to understand or follow the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Related Publications (1)

  • Hulot JS, Bura A, Villard E, Azizi M, Remones V, Goyenvalle C, Aiach M, Lechat P, Gaussem P. Cytochrome P450 2C19 loss-of-function polymorphism is a major determinant of clopidogrel responsiveness in healthy subjects. Blood. 2006 Oct 1;108(7):2244-7. doi: 10.1182/blood-2006-04-013052. Epub 2006 Jun 13.

    PMID: 16772608RESULT

MeSH Terms

Interventions

Clopidogrel

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jean Sébastien HULOT, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2006

First Posted

December 20, 2006

Study Start

January 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

May 5, 2011

Record last verified: 2007-07

Locations

FR(1)