NCT02017197 - Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil | Biotech Hunter

Enrollment

100

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions

Atrial Fibrillation

Interventions

DRUG

Marevan®

Branded warfarin sodium tablets (manufacturer União Química Farmacêutica Nacional S/A, Brazil) by mouth; dose adjusted according to INR and medical judgement.

DRUG

generic warfarin #1

Generic warfarin sodium tablets, manufacturer (União Química Farmacêutica Nacional S/A, Brazil), by mouth; dose adjusted according to INR and medical judgement.

DRUG

generic warfarin #2

Generic warfarin sodium tablets, manufacturer (Laboratório Teuto Brasileiro S/A, Brazil), by mouth; dose adjusted according to INR and medical judgement.

Trial Locations (1)

04024-002

Hospital São Paulo/Hospital Universitário da UNIFESP (University Hospital of UNIFESP), São Paulo

All Listed Sponsors

collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

lead

Federal University of São Paulo

OTHER