Trial · NCT01679587
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 | Approximately 9 weeks | |
| Primary | Blood pressure | Approximately 9 weeks | Systolic, diastolic, mean blood pressure |
| Primary | Heart rate | Approximately 9 weeks | |
| Primary | Cmax | Pre-dose and up to 48 h post-dose | Maximum observed drug concentration in measured matrix after single dose administration |
| Primary | Cmax/D | Pre-dose and up to 48 h post-dose | Cmax divided by dose |
| Primary | AUC | Pre-dose and up to 48 h post-dose | Area under the concentration vs time curve from zero to infinity after single dose |
| Primary | AUC/D | Pre-dose and up to 48 h post-dose | AUC divided by dose |
| Primary | Heart rate over 1 min | Pre-dose and up to 24 h post-dose | |
| Primary | Standing blood pressure procedure | Starting from 2 h post-dose and up to 4 h post-dose | |
| Primary | Impedance cardiography | Pre-dose and up tp 8 h post-dose | Stroke volume, heart rate, cardiac index, cardiac output, and total peripheral resistance |
| Secondary | Change of hematology profile | From baseline to Day 1 after single dose | Hematology profile includes blood concentration of erythropoietin, reticulocytes, erythrocytes, hemoglobin, hematocrit, and exploratory biomarkers. |
| Secondary | Cmax,norm | Pre-dose and up to 48 h post-dose | Cmax divided by dose per body weight |
| Secondary | AUCnorm | Pre-dose and up to 48 h post-dose | AUC divided by dose per body weight |
| Secondary | AUC(0-24) | Pre-dose and up to 24 h post-dose | AUC from 0 until 24 h after study drug administration |
| Secondary | AUC(0-tlast) | Pre-dose and up to 48 h post-dose | AUC from time 0 to the last data point \> lower limit of quantification |
| Secondary | t½ | Pre-dose and up to 48 h post-dose | Half-life associated with the terminal slope |
| Secondary | tmax | Pre-dose and up to 48 h post-dose | Time to reach Cmax (in case of two identical Cmax values, the first tmax was used) |
| Secondary | MRT | Pre-dose and up to 48 h post-dose | Mean residence time |
| Secondary | CL/F | Pre-dose and up to 48 h post-dose | Total body clearance of drug calculated after extravascular administration (eg, apparent oral clearance) |
| Secondary | Vz/F | Pre-dose and up to 48 h post-dose | Apparent volume of distribution during terminal phase after extravascular administration |
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/NCT01679587/registered