Trial · NCT03447990
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose to 30 days post last dose (Up to 2 months) | All treated participants per regimen dosage | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - SAD Cohorts | Baseline, day 1-16, 2 hours pre-dose and at 3-, 5-, 9-, 12-, 24-, and 36-hours post-dose | All treated participants in SAD Cohorts per regimen dosage | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - MAD Cohorts | Baseline, Day 1-16, 2 hours pre-dose and at 7-, 24-, and 48-hours post final dose | All treated participants in MAD Cohorts per regimen dosage | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Mean Change From Baseline in Vital Signs Part 1 - SAD Cohorts | Baseline and at 6-hours post-dose | All treated participants in SAD Cohorts per regimen dosage | mmHg | MEAN |
| PRIMARY | Mean Change From Baseline in Vital Signs Part 1 - MAD Cohorts | Baseline and at 6-hours post-dose | Pre-specified for data to be collected by combining all treated participants with vital signs measurements in MAD Cohorts per regimen only | mmHg | MEAN |
| PRIMARY | Mean Change From Baseline in Vital Signs Part 2 - SAD Cohorts | Baseline and at 6-hours post-dose | All treated participants in SAD Cohorts per regimen dosage | Beats/min | MEAN |
| PRIMARY | Mean Change From Baseline in Vital Signs Part 2 - MAD Cohorts | Baseline and at 6-hours post-dose | Pre-specified for data to be collected by combining all treated participants with vital signs measurements in MAD Cohorts per regimen only | Beats/min | MEAN |
| PRIMARY | Number of Participants With a Troponin I Increase - SAD Cohorts | Baseline, day 1-3, 2 hours pre-dose and at 3-, 5-, 9-, 12-, 24-, and 36-hours post-dose | Pre-specified for data to be collected by combining all treated participants in SAD Cohorts per regimen only | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Troponin I Increase - MAD Cohorts | Baseline, pre-dose and 7hr post dose on treatment day 1, day 2, day 5 and pre-dose and at 7-, 24-, and 48-hours post final dose | Pre-specified for data to be collected by combining all treated participants in MAD Cohorts per regimen only | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Laboratory Abnormalities | From first dose to 30 days post last dose (Up to 2 months) | Pre-specified for data to be collected by combining all treated participants per SAD and MAD Cohort only | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Physical Examinations Abnormalities | From first dose to 30 days post last dose (Up to 2 months) | Pre-specified for data to be collected by combining all treated participants per SAD and MAD Cohort only | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Danicamtiv Maximum Observed Plasma Concentration (Cmax) | 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdose | All participants that received Danicamtiv with plasma concertation data | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Danicamtiv Time of Maximum Observed Plasma Concentration (Tmax) | 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdose | All participants that received Danicamtiv with plasma concertation data | hours | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve (AUC) | 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdose | All participants that received Danicamtiv with plasma concertation data | hr x ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Apparent First-order Terminal Elimination Half-life (t1/2) | 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdose | All participants that received Danicamtiv with plasma concertation data | hours | MEAN |
| SECONDARY | Danicamtiv Accumulation Ratio for Maximum Observed Plasma Concentration AR(Cmax) - MAD Cohorts | 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdose | All participants in MAD Cohorts that received Danicamtiv with plasma concertation data | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Accumulation Ratio for Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours AR(AUC(0-12)) - MAD Cohorts | 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdose | All participants in MAD Cohorts that received Danicamtiv with plasma concertation data | hr x ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 1 - SAD Cohorts | Baseline, predose and at 3, 6, 9, and 24 hours post dose | All treated participants in SAD Cohorts per Danicamtiv plasma concentration ranges (Reporting arms are not mutually exclusive) | msec | MEAN |
| SECONDARY | Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 2 - SAD Cohorts | Baseline, predose and at 3, 6, 9, and 24 hours post dose | All treated participants in SAD Cohorts per Danicamtiv plasma concentration ranges (Reporting arms are not mutually exclusive) | mL | MEAN |
| SECONDARY | Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 3 - SAD Cohorts | Baseline, predose and at 3, 6, 9, and 24 hours post dose | All treated participants in SAD Cohorts per Danicamtiv plasma concentration ranges (Reporting arms are not mutually exclusive) | Percentage of blood pumped from LV | 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.
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GET https://conductscience.org/api/trials/v1/NCT03447990/outcomes