Trial · NCT04572893
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. |
| 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) | An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event. |
| 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) | Number of participants with safety laboratory assessments by intensity. Mild=An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; Moderate= An event causing sufficient discomfort and interferes with normal everyday activities. |
| 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) | Number of participants with clinically significant changes in physical examinations. |
| 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) | Number of participants with clinically significant changes in vital signs. |
| 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) | Number of participants with clinically significant changes in 12-lead ECG recordings. |
| 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) | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Mild=An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; Moderate= An event causing sufficient discomfort and interferes with normal everyday activities. Severe= An event preventing normal everyday activities. (An AE that is assessed as severe should not be confused with a SAE. Severe is a category utilized for rating the intensity of an event; and both AEs and SAEs can be assessed as severe.) |
| 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 | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| 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 | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| 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 | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| 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 | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| 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 | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| 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 | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| 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 | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| 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 | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| 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 | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| 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 | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| 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 | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| 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 | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| 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 | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
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
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GET https://conductscience.org/api/trials/v1/NCT04572893/registered