Trial · NCT02386358
Etiologic Treatment With Benznidazole in Adult Patients With Chronic Chagas Disease. A Randomized Clinical Trial
NCT02386358, Phase 3, Completed, Instituto Nacional de Parasitologia Dr. Mario Fatala Chaben
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Etiologic Treatment With Benznidazole in Adult Patients With Chronic Chagas Disease. A Randomized Clinical Trial. Trials, record NCT02386358. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02386358
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Etiologic Treatment With Benznidazole in Adult Patients With Chronic Chagas Disease. A Randomized Clinical Trial
- NCT number
- NCT02386358
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 910 participants, actual
- Lead sponsor
- Instituto Nacional de Parasitologia Dr. Mario Fatala Chaben
- Conditions
- Chagas Disease
- Interventions
- Benznidazole, Placebo
- First posted
- 2015-03-11
- Last updated
- 2015-03-11
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cardiovascular Mortality | Time to event: from date of randomization until the date of first documented progression or date of death from any cause up to 10 years of follow-up | Sudden death, unexpectedly in time and in its presentation,preceded by the abrupt loss of consciousness within a maximum of one hour of the onset of symptoms,when it happened during sleep or unexpectedly in a patient was stable until then. Related Death, when presented in a patient with signs of progressive heart failure.Ischemic or Hemorrhagic Stroke |
| Primary | Development of heart failure | Time to event: from date of randomization until the date of first documented progression of heart failure up to 10 years of follow-up | Dyspnea is evaluated according to the classification of the New York Heart Association (NYHA),gallop rhythm, jugular venous distension, crackles in the lungs, edema or pleural effusion,hepatomegaly |
| Primary | Severe arrhythmias with hemodynamic compromise or pacemaker implant or Implantable cardiac defibrillator | Time to event: from date of randomization until the date of first documented progression up to 10 years of follow-up | Sustained ventricular tachycardia, atrioventricular block, trifascicular block, Atrial fibrillation |
| Secondary | Electrocardiographic endpoints. New development of permanent changes in the electrocardiographic | Time to event: from date of randomization until the date of first documented as defined in the secondary outcome up to 10 years of follow-up | * Stable sinus bradycardia (\<50 beats / min) * Auriculoventricular blocks of 2nd and 3rd degree * Left anterior hemi-block * Complete right bundle branch block * Atrial flutter or fibrillation * Sustained ventricular tachycardia |
| Secondary | Changes in clinical stage in chronic Chagas disease | Time to event: from date of randomization until the date of first documented as defined in the secondary outcome up to 10 years of follow-up | Clinical progression |
| Secondary | Enlargement of the left ventricle (LV) detected by echocardiography. | Time to event: from date of randomization until the date of first documented as defined in the secondary outcome up to 10 years of follow-up | Clinical Progression |
| Secondary | New Heart Failure | Time to event: from date of randomization until the date of first documented as defined in the secondary outcome up to 10 years of follow-up | Clinical Progression |
| Secondary | Stroke | Time to event: from date of randomization until the date of first documented as defined in the secondary outcome up to 10 years of follow-up | Clinical progression |
| Secondary | Serological negativization | time to event: from the date of randomization to the date of the first documented serological negativization that persists until 10 years of follow-up | by ELISA F29 vs. conventional serology as a late indicator of efficacy or therapeutic failure. |
| Secondary | Development and validation of RT-PCR | time to event: from the date of randomization to the date of the first documented no detectable RT-PCR that persists until 10 years of follow-up | Demonstration of RT-PCR as an early indicator of efficacy or therapeutic failure. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02386358
GET https://conductscience.org/api/trials/v1/NCT02386358/registered