Trial · NCT05399550
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Amount of midline shift (MLS) at 72 hours from Last Known Well (LKW) | 72 Hours from Last Known Well | Midline shift will be measured in millimeter on non-contrast computer tomography (NCCT) |
| Secondary | Percentage of Participants with modified Rankin Scale-Structured Interview (mRS-SI) score </= 4 vs. >4 | At Day 90 | |
| Secondary | Amount of MLS | At 48 hours and 96-120 hours from LKW | MLS will be measured in millimeter on NCCT |
| Secondary | Percentage of Participants with Surgical DHC Performed | From Baseline up to Day 90 | |
| Secondary | Percentage of Participants Who Received Hyperosmolar therapy following initiation of study treatment | From Baseline up to Day 90 | |
| Secondary | National Institute of Health Stroke Scale (NIHSS) score | At Day 4 and Day 90 | |
| Secondary | Mortality | At Day 30 | Mortality in the first 30 days after the enrollment |
| Secondary | mRS-SI score | At Day 30 | |
| Secondary | Functional Independence Measure (FIM) score | At Discharge or Day 10 and Day 90 | |
| Secondary | Glasgow Outcome Scale Extended (GOSE) Score | at Discharge or Day 10, Day 30 and Day 90 | |
| Secondary | Stroke Impact Scale-16 (SIS-16) score | At Day 30 and Day 90 | |
| Secondary | Length (in days) of ICU and Hospital Stay | From Baseline to Day 90 | |
| Secondary | Number of participants with adverse events and severity of adverse events | From Baseline to Day 90 | Severity will be determined according to the NCI CTCAE v5.0 |
| Secondary | Plasma concentrations of balovaptan at specified timepoints | From Baseline to 120 Hours After the End of the Last Infusion (or at discharge) | |
| Secondary | Area under the concentration-time curve from Time 0 to 24 hours after a given dose (AUC24hr) | From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)] | As calculated by NCA from measured concentration |
| Secondary | Maximum observed concentration (Cmax) | From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)] | As calculated by NCA or taken directly from measured concentration |
| Secondary | Plasma drug concentration 24hours after the administration of a given dose (C24hr) | From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)] | As calculated by NCA or taken directly from measured concentration |
| Secondary | Number of participants with safety findings on brain imaging | From Baseline to Day 90 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05399550/registered