BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas' Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

2,854

Participants

Timeline

Start Date

November 30, 2004

Primary Completion Date

July 31, 2015

Study Completion Date

August 31, 2015

Conditions
Chagas DiseaseTrypanosomiasisHeart Disease
Interventions
DRUG

Benznidazole

Daily po Benznidazole or placebo (weight based) during 40 - 80 days (depending on body weight)

DRUG

Placebo

a dose calculated as 5mg/kg/day for 60 days, now administered as a fixed daily dose of 300mg during 40 - 80 days of treatment - period adjusted according to the patient's body weight to a total minimum dose of 12g (corresponding to 40kg) and a total maximum dose of 24g (corresponding to 80kg)

Trial Locations (47)

1063

BENEFIT Investigational Site, Buenos Aires

1282

BENEFIT Investigational Site, Isidro Casanova

1625

BENEFIT Investigational Site, San Juan

1753

BENEFIT Investigational Site, Belén de Escobar

2000

BENEFIT Investigational Site, Rosario

3100

BENEFIT Investigational Site, Paraná

3400

BENEFIT Investigational Site, Corrientes

3556

BENEFIT Ivestigational Site, Buenos Aires

3760

BENEFIT Investigational Site, Añatuya

4200

BENEFIT Investigational Site, Santiago Del Estero

BENEFIT Investigational Site, Santiago del Estero

4600

BENEFIT Investigational Site, San Salvador de Jujuy

5400

BENEFIT Investigational Site, Santiago Del Estero

Unknown

BENEFIT Investigational Site, Catamarca

BENEFIT Investigational Site, Buenos Aires

BENEFIT Investigational Site, Buenos Aires

BENEFIT Investigational Site, Tupiza

BENEFIT Investigational Site, Bogotá

BENEFIT Investigational Site, San Gil

BENEFIT Ivestigational Site, San Salvador

H3730AVI

BENEFIT Investigational Site, Charata

A4406CLA

BENEFIT Investigational Site, Salta

40050-410

BENEFIT Investigational Site, Salvador

40110-909

BENEFIT Investigational Site, Salvador

40425-060

BENEFIT Investigational Site, Salvador

30130-690

BENEFIT Investigational Site, Carmo

70658-700

BENEFIT Investigational Site, Brasília

74110-010

BENEFIT Investigational Site, Goiânia

74110-020

BENEFIT Investigational Site, Goiânia

74605-050

BENEFIT Investigational Site, Goiânia

38010-160

BENEFIT Investigational Site, Uberaba

38025-440

BENEFIT Investigational Site, Uberlândia

38400-299

BENEFIT Investigational Site, Uberlândia

80060-900

BENEFIT Investigational Site, Curitiba

50100-130

BENEFIT Investigational Site, Recife

96015-290

BENEFIT Investigational Site, Pelotas

13059-740

BENEFIT Investigational Site, Campinas

14048-900

BENEFIT Investigational Site, Ribeirão Preto

15015-210

BENEFIT Investigational Site, São José do Rio Preto

15090-000

BENEFIT Investigational Site, São José do Rio Preto

15500-003

BENEFIT Investigational Site, Votuporanga

21040-360

BENEFIT Investigational Site, Rio de Janeiro

21941-913

BENEFIT Investigational Site, Rio de Janeiro

01417 010

BENEFIT Investigational Site, São Paulo

04012-909

BENEFIT Investigational Site, São Paulo

05403-000

BENEFIT Investigational Site, São Paulo

05403-901

BENEFIT Investigational Site, São Paulo

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

World Health Organization

OTHER

collaborator

Instituto Dante Pazzanese de Cardiologia

OTHER

collaborator

University of Sao Paulo

OTHER

lead

Population Health Research Institute

OTHER

NCT00123916 - BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas' Disease | Biotech Hunter | Biotech Hunter