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Comparison of Generic and Original Formulation of Clopidogrel

NCT01147133 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2013-01-29

No results posted yet for this study

Summary

Clopidogrel is essential for the prevention of vascular events in patients after percutaneous coronary interventions (PCI). Most of our current knowledge with clopidogrel originates from the clinical investigations that had used Plavix®/Iscover® from Sanofi-Aventis as the original formulation of clopidogrel-bisulphate. However, as the patency of Plavix® has expired in November 2009 in Hungary, several generic clopidogrel have been introduced to the market. Some of the generics are using the original bisulphate formulation, while others are with besylate salt of clopidogrel. Despite the differences in the clopidogrel-salts, the different carriers might also modulate the pharmacokinetic/pharmacodynamic profile of each drug. As the consequences of the impaired antiplatelet potency might be devastating, including stent thrombosis, the investigators sought to compare generic clopidogrel to the original blister by different assays of platelet aggregation.

Conditions

Interventions

DRUG

Plavix

1x75 mg

DRUG

Kardogrel

1x75 mg

Sponsors & Collaborators

  • Hungarian Academy of Sciences

    collaborator OTHER

  • KRKA

    collaborator INDUSTRY

  • University of Pecs

    lead OTHER

Principal Investigators

  • Daniel Aradi, MD PhD · University of Pécs, HUNGARY

  • András Komócsi, MD PhD · University of Pécs, HUNGARY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-04-30
Completion
2010-05-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01147133 on ClinicalTrials.gov