Trial · NCT04572893
Outcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) in Part A | From first dose to 30 days post last dose (Up to approximately 15 weeks) | All treated participants in Part A as pre-specified in protocol. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) in Part A | From first dose to 30 days post last dose (Up to approximately 15 weeks) | All treated participants in Part A as pre-specified in protocol. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | From first dose to 14 days post last dose (Up to approximately 13 weeks) | All treated participants in Part A as pre-specified in protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | All treated participants with baseline and post baseline measurements at the specified timepoints | msec | MEAN |
| PRIMARY | Number of Participants With Clinically Significant Changes in Physical Examinations in Part A | From first dose to 30 days post last dose (Up to approximately 15 weeks) | All treated participants in Part A as pre-specified in protocol | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Vital Signs in Part A | From first dose to 30 days post last dose (Up to approximately 15 weeks) | All treated participants in Part A as pre-specified in protocol | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in 12-Lead ECG Recordings in Part A | From first dose to 30 days post last dose (Up to approximately 15 weeks) | All treated participants in Part A as pre-specified in protocol | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A | From first dose to 14 days post last dose (Up to approximately 13 weeks) | All treated participants in Part A as pre-specified in protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | All treated participants with baseline and post baseline measurements at the specified timepoints | mL | MEAN |
| SECONDARY | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination | All treated participants with baseline and post baseline measurements at the specified timepoints | percentage | MEAN |
| SECONDARY | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination | All treated participants with baseline and post baseline measurements at the specified timepoints | percentage | MEAN |
| SECONDARY | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination | All treated participants with baseline and post baseline measurements at the specified timepoints | percentage | MEAN |
| SECONDARY | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | All treated participants with baseline and post baseline measurements at the specified timepoints | cm/s | MEAN |
| SECONDARY | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | All treated participants with baseline and post baseline measurements at the specified timepoints | cm/s | MEAN |
| SECONDARY | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | All treated participants with baseline and post baseline measurements at the specified timepoints | mm | MEAN |
| SECONDARY | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination | All treated participants with baseline and post baseline measurements at the specified timepoints | mL/m^2 | MEAN |
| SECONDARY | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | All treated participants with baseline and post baseline measurements at the specified timepoints | mm | MEAN |
| SECONDARY | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination | All treated participants with baseline and post baseline measurements at the specified timepoints | m1/m2 | MEAN |
| SECONDARY | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | All treated participants with baseline and post baseline measurements at the specified timepoints | cm/s | MEAN |
| SECONDARY | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | All treated participants with baseline and post baseline measurements at the specified timepoints | cm/s | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04572893/outcomes