Trial · NCT05167825
Registered outcomes45
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 45
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Fold Change From Baseline at Week 24 in Pulmonary Vascular Resistance Index (PVRI) | Baseline (Day 1), Week 24 | PVRI fold change at Week 24 was calculated as 100\*(PVRI at Week 24 divided by PVRI at baseline). PVR was determined by right heart catheterization. |
| Primary | Change From Baseline in Hematology Parameter: Neutrophils Band Form (NBF) | Baseline (Day 1), Weeks 8, 16, 20, 40, 52 | Change from baseline in hematology parameters: NBF was reported. Data for each parameters was planned to be reported at specified timepoints only. |
| Secondary | Change From Baseline to Week 24 in Hemodynamic Variable: Pulmonary Vascular Resistance (PVR) | Baseline (Day 1), Week 24 | Change from baseline to Week 24 in hemodynamic variable: PVR was reported. PVR is calculated as: PVR= (Mean pulmonary artery pressure \[mPAP\]-Pulmonary artery wedge pressure \[PAWP)/ Cardiac output \[CO\]. |
| Secondary | Change From Baseline to Week 24 in Hemodynamic Variable: Mean Right Atrial Pressure (mRAP) | Baseline (Day 1), Week 24 | Change from baseline to Week 24 in hemodynamic variable: mRAP was reported. |
| Secondary | Change From Baseline to Week 24 in Hemodynamic Variable: Mean Pulmonary Arterial Pressure (mPAP) | Baseline (Day 1), Week 24 | Change from baseline to Week 24 in hemodynamic variable: mPAP was reported. mPAP is calculated as: 2\*diastolic pulmonary arterial pressure (dPAP) + systolic pulmonary arterial pressure (sPAP)/3. |
| Secondary | Change From Baseline to Week 24 in Hemodynamic Variable: Cardiac Index (CI) | Baseline (Day 1), Week 24 | Change from baseline to Week 24 in hemodynamic variable: CI was reported. CI was calculated as: CO/Body surface area (BSA). |
| Secondary | Change From Baseline to Week 24 in Hemodynamic Variable: Cardiac Output (CO) | Baseline (Day 1), Week 24 | Change from baseline to Week 24 in hemodynamic variable: CO was reported. |
| Secondary | Change From Baseline to Week 24 in Hemodynamic Variable: Total Pulmonary Resistance (TPR) | Baseline (Day 1), Week 24 | Change from baseline to Week 24 in hemodynamic variable: TPR was reported. TPR was calculated as: (mPAP/CO)\*80. |
| Secondary | Percent Change From Baseline to Week 24 in Hemodynamic Variable: Mixed Venous Oxygen Saturation (SvO[2]) | Baseline (Day 1), Week 24 | Percent change from baseline to Week 24 in hemodynamic variable: SvO(2) was reported. |
| Secondary | Number of Participants With Change From Baseline at Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52 in World Health Organization (WHO) Functional Class (FC) | Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52 | WHO-FC for participants with pulmonary arterial hypertension (PAH) ranges: Class I (no limitation in physical activity, ordinary physical activity did not cause undue dyspnea or fatigue, chest pain or near syncope), Class II (slight limitation of physical activity, comfortable at rest, ordinary physical activity caused undue dyspnea or fatigue, chest pain, or near syncope), Class III (marked limitation of physical activity, comfortable at rest, less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope) and Class IV (cannot perform a physical activity without any symptoms, signs of right heart failure, dyspnea and/or fatigue may be present even at rest, discomfort is increased by any physical activity). Participants who improve in WHO FC are reported below. Improvement was defined as reduction in FC. |
| Secondary | Number of Participants With Change From Baseline at Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52 in Panama Functional Class (FC) | Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52 | Panama FC for PAH ranges: Class I (asymptomatic, growing normally, attending nursery/school regularly, no limitation of physical activity, playing sports with his/her classmates), Class II (slight limitation of physical activity, unduly dyspnoeic and fatigued when playing with his/her classmates, comfortable at rest, grow along own centiles, nursery/school attendance 75% normal, no chest pain), Class IIIa (marked limitation of physical activity, no attempt at sports, comfortable at rest, less than ordinary activity (example: dressing) causes undue dyspnea, fatigue, syncope and/or presyncope or chest pain, nursery/schooling compromised \<50% normal attendance), Class IIIb (growth compromised, poor appetite, supplemental feeding, same as class IIIa) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Participants who improve in Panama FC are reported below. Improvement was defined as reduction in Panama FC. |
| Secondary | Change From Baseline to Weeks 24 and 52 in 6-minute Walk Distance (6MWD) as Measured by the 6-minute Walk Test (6MWT) | Baseline (Day 1), Weeks 24 and 52 | Change from baseline to Weeks 24 and 52 in 6MWD as measured by 6MWT was reported. 6MWD was the distance that a participant could walk in 6 minutes. Rest periods were allowed if the participant could no longer continue. If the participant need to rest, he/she may pause, lean against the wall and continue walking whenever he/she feels able. The timer continued to run even if the participant stopped to rest. |
| Secondary | Change From Baseline to Weeks 12, 24, 28, 40, and 52 in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) | Baseline (Day 1), Week 12, 24, 28, 40, and 52 | Change from baseline to Weeks 12, 24, 28, 40, and 52 in NT-proBNP was reported. |
| Secondary | Change From Baseline to Weeks 12, 24, and 52 in Tricuspid Annular Plane Systolic Excursion (TAPSE) | Baseline (Day 1), Weeks 12, 24, and 52 | Change from baseline to Weeks 12, 24, and 52 in TAPSE was reported. It was calculated as: original TAPSE value/body surface area (BSA). TAPSE was a dimension used to evaluate Right Ventricle (RV) longitudinal systolic function; it measured the extent of systolic motion of the lateral portion of the tricuspid ring towards the apex. |
| Secondary | Change From Baseline to Week 12, 24, and 52 in Left Ventricular Eccentricity Index (LVEI) | Baseline (Day 1), Weeks 12, 24 and 52 | Change from baseline to Weeks 12, 24, and 52 in LVEI was reported. It included diastolic (D) LVEI and systolic (S) LVEI. Left ventricular (LV) internal diameters were measured using the parasternal short axis view at the level of the papillary muscles: D1: LV internal diameter perpendicular to interventricular septum at end-diastole; D2: LV internal diameter parallel to interventricular septum, and at right angle from D1, at end-diastole; S1: LV internal diameter perpendicular to interventricular septum at end-systole; S2: LV internal diameter parallel to interventricular septum, and at a right angle from S1, at end-systole. The LVEI was a ratio that was calculated by sponsor as: LVEI diastole = D2/D1; LVEI systole = S2/S1. |
| Secondary | Change From Baseline to Week 12, 24, and 52 in Quality of Life (QoL) as Assessed by Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales Short Form (SF-15) | Baseline (Day 1), Weeks 12, 24, and 52 | Change from baseline to Weeks 12, 24, and 52 in QoL as assessed by PedsQL 4.0 generic core scales SF-15 was reported. The PedsQL 4.0 questionnaire generic core scales score SF-15 assessed general physical, emotional, social and school functioning on a 5-point Likert scale from 0 to 4 with 0= if it is never a problem, 1= if it is almost never a problem, 2= if it is sometime a problem, 3= if it is often a problem, 4 if it is almost always a problem. Scores were transformed on a scale from 0 to 100. Higher scores indicated better health related QoL. The QoL questionnaire was completed by parent(s)/caregiver(s) and by participants. |
| Secondary | Change From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Number of Hours of Daytime Activity | Baseline (Day 1), Weeks 12, 24, and 52 | Change from baseline to Weeks 12, 24, and 52 in physical activity as measured by accelerometry: number of hours of daytime activity was reported. |
| Secondary | Change From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Mean Count Per Minute of Daily Activity | Baseline (Day 1), Weeks 12, 24, and 52 | Change from baseline to Weeks 12, 24, and 52 in physical activity as measured by accelerometry: mean count per minute of daily activity was reported. |
| Secondary | Change From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Mean Daily Time Spent in Light Physical Activity | Baseline (Day 1), Weeks 12, 24, and 52 | Change from baseline to Weeks 12, 24, and 52 in physical activity as measured by accelerometry: mean daily time spent in light physical activity was reported. |
| Secondary | Change From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Mean Daily Time Spent in Moderate to Vigorous Physical Activity | Baseline (Day 1), Weeks 12, 24, and 52 | Change from baseline to Weeks 12, 24, and 52 in physical activity as measured by accelerometry: mean daily time spent in moderate to vigorous physical activity was reported. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
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