Trial · NCT00159913
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Intent To Treat Population | Baseline, Week 16 | Peak VO2 (normalized for body weight) at trough plasma levels assessed by CPX testing (bicycle ergometry)at the end of treatment (Week 16 for those who completed the study). Mean Percent change = \[(week 16 value minus baseline mean)/mean at baseline\]\*100%. |
| Primary | Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Per Protocol Population | Baseline, Week 16 | Peak VO2 (normalized for body weight) at trough plasma levels assessed by CPX testing (bicycle ergometry)at the end of treatment (Week 16 for those who completed the study). Mean Percent change = \[(week 16 value minus baseline mean)/mean at baseline\]\*100%. |
| Secondary | Change From Baseline to Week 16 in Mean Pulmonary Artery Pressure (mPAP) | Baseline, Week 16 | mPAP, a hemodynamic parameter, was measured using a pressure transducer positioned at the mid-axillary line with the patient in the supine position. Change is observed value at Week 16 minus Baseline value. |
| Secondary | Change From Baseline to Week 16 in Pulmonary Vascular Resistance Index (PVRI) | Baseline, Week 16 | PVRI equals Pulmonary Vascular Resistance (PVR) times Body Surface Area (BSA). Wood unit = 80dyn•s/cm5. Change is observed value at Week 16 minus Baseline value. |
| Secondary | Percent Change From Baseline to Week 16 in: Respiratory Exchange Ratio (RER) | Baseline, Week 16 | RER is the ratio of carbon dioxide produced to oxygen consumed \[VCO2/VO2\]). Percent change is \[(Week 16 value minus Baseline value)/Baseline value\] \* 100% |
| Secondary | Percent Change From Baseline to Week 16 in Time to Maximum Volume of Oxygen Consumed (VO2) | Baseline, Week 16 | Time to maximum VO2 was assessed on the subset of subjects who are developmentally able to perform the exercise test. Percent change is \[(value at Week 16 minus Baseline value)/Baseline value\] \* 100% |
| Secondary | Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) | Baseline, Week 16 | Change calculated as (mean PAP - PCWP)/COpulm in PVR is observed value at Week 16 minus Baseline value. |
| Secondary | Change From Baseline to Week 16 in Cardiac Index (CI) | Baseline, Week 16 | CI is observed value at Week 16 minus Baseline value. Calculated as cardiac output in systemic circulation (COsys) / body surface area (BSA). |
| Secondary | Change From Baseline to Week 16 in Right Atrial Pressure (RAP) | Baseline, Week 16 | RAP was measured using a pressure transducer positioned at the mid-axillary line with the patient in the supine position. Change is observed value at Week 16 minus Baseline value. |
| Secondary | Change From Baseline to Week 16 in Child Health Questionnaire Parent Form (CHQ-PF28), Physical Scale | Baseline, Week 16 | CHQ-PF28: validated generic Quality of Life (QoL) questionnaire for subjects \>= 5 years. Includes 12 domain scores of QoL concepts including physical functioning, social \& school activities, mental health, parent/family concepts. Scores range 0-100: lower scores = lower QoL. Change is observed value at Week 16 minus Baseline value. |
| Secondary | Change From Baseline to Week 16 in Child Health Questionnaire Parent Form (CHQ-PF28), Psychosocial Scales | Baseline, Week 16 | CHQ-PF28: validated generic Quality of Life (QoL) questionnaire for subjects \>= 5 years. Includes 12 domain scores of QoL concepts including physical functioning, social \& school activities, mental health, parent/family concepts. Scores range 0-100: lower scores = lower QoL. Change is observed value at Week 16 minus Baseline value. |
| Secondary | Change From Baseline to Week 16 in World Health Organization (WHO) Pulmonary Hypertension (PH) Functional Class | Baseline, Week 16 | WHO PH functional class definitions adapted from New York Heart Association Criteria for Functional Capacity and Therapeutic Class Definitions. Class I = PH without resulting limitation of physical activity, Class II = PH resulting in slight limitation of physical activity, Class III = PH resulting in marked limitation of physical activity, Class IV = PH with inability to carry out any physical activity without symptoms. Improved by 1 class = Class 4 to 3, Class 3 to 2, Class 2 to 1. Improved by 2 classes = Class 4 to 2, Class 3 to 1. Change is observed value at Week 16 minus Baseline value. |
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.
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