Trial · NCT03340675
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment-Emergent Adverse Events | Baseline through 12 months | Percentage of subjects with one or more treatment emergent adverse event |
| Secondary | Pharmacokinetics Area Under the Curve | Pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post-dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7 | Plasma ifetroban and its acyl glucuronide metabolite were measured pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7. Area under the curve until the last measurement was calculated for the plasma concentration versus time curves for ifetroban and its acyl glucuronide metabolite after administration of assigned oral ifetroban dose |
| Secondary | Pharmacokinetics Maximum Serum Concentration (Cmax) | Pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7 | Plasma ifetroban and its acyl glucuronide metabolite were measured pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7 to determine the maximum plasma concentration of ifetroban and its acyl glucuronide metabolite after administration of assigned oral ifetroban dose |
| Secondary | Pharmacokinetics Time to Reach Cmax (Tmax) Concentration | Pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7 | Plasma ifetroban and its acyl glucuronide metabolite were measured pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7 to determine the time to maximum plasma concentration of ifetroban and its acyl glucuronide metabolite following administration of assigned oral ifetroban dose |
| Secondary | Pharmacokinetics Plasma Terminal Half-life Concentration | Pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7 | Plasma ifetroban were measured pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7. The terminal elimination half-life was calculated from the plasma concentration versus time curves for ifetroban following administration of assigned oral ifetroban dose |
| Secondary | Change From Baseline in Left Ventricular Ejection Fraction | Baseline visit and Month 12 visit | Change from baseline at month 12 in left ventricular ejection fraction |
| Secondary | Change From Baseline in FEV1 | Baseline through month 12 | Change from baseline at month 12 in Forced Expiratory Volume in 1 second |
| Secondary | Change From Baseline in Percent Predicted FEV1 | Baseline through month 12 | Change from baseline at month 12 in percent predicted Forced Expiratory Volume in 1 second |
| Secondary | Change From Baseline in FVC | Baseline through month 12 | Change from baseline at month 12 in Forced Vital Capacity |
| Secondary | Change From Baseline in Percent Predicted FVC | Baseline through month 12 | Change from baseline at month 12 in percent predicted Forced Vital Capacity |
| Secondary | Change From Baseline in Maximal Expiratory Pressure | Baseline through month 12 | Change from baseline at month 12 in maximal expiratory pressure |
| Secondary | Change From Baseline in Maximal Inspiratory Pressure | Baseline through month 12 | Change from baseline at month 12 in maximal inspiratory pressure |
| Secondary | Change From Baseline in Peak Expiratory Flow Rate | Baseline through month 12 | Change from baseline at month 12 in peak expiratory flow rate |
| Secondary | Change From Baseline in Percent Predicted Peak Expiratory Flow Rate | Baseline through month 12 | Change from baseline at month 12 in percent predicted peak expiratory flow rate |
| Secondary | Change From Baseline in Quality-of-life | Baseline through 12 months | The Pediatric Quality of Life Inventory (PedQL) questionnaire measures core dimensions of health as delineated by the World Health Organization. The core module includes 23 items comprising 14 dimensions. The Gastrointestinal module includes 74 items comprising 14 dimensions. The Neuromuscular module includes 25 items comprising 3 dimensions. Each item in the modules is measured on a 5-point Likert scale of 0-4 with 0 indicating 'never' and 4 indicating 'almost always'. The Likert scores for each subscale are reversed scored and linearly transform to a 0-100 scale with 0=100, 1-75, 2=50, 5=25, and 4=0. A higher score indicates better health-related quality of life. Subscale scores are averaged to generate the total score reported with a range of 0-100. Results are presented as change from baseline at 12 months. The questionnaire was completed by the participant and the parent/guardian of the participant. |
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/NCT03340675/registered