Trial · NCT02932410
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight | Pre-dose at Week 12 | The Pharmacokinetics (PK) 1 set included all participants aged \>=2 years randomized to and treated with macitentan, for whom a PK blood sample at trough had been taken and who did not deviate from the protocol in a way that affected the evaluation of the PK trough endpoints. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and n(number analyzed) signifies number of participants analyzed for specified categories. | nanograms per milliliter (ng/mL) | MEAN |
| PRIMARY | Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Age Group | Pre-dose at Week 12 | The Pharmacokinetics (PK) 1 set included all participants aged \>=2 years randomized to and treated with macitentan, for whom a PK blood sample at trough had been taken and who did not deviate from the protocol in a way that affected the evaluation of the PK trough endpoints. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and n(number analyzed) signifies number of participants analyzed for specified categories. | nanograms per milliliter (ng/mL) | MEAN |
| PRIMARY | Participants <2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 4 | Pre-dose at Week 4 | PK Set 3 included all participants aged \<2 years and treated with macitentan for whom a PK blood sample had been taken and who did not deviate from the protocol in a way that might affect the evaluation of the PK endpoints. | ng/mL | MEAN |
| PRIMARY | Participants From China With >=12 to <18 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 | Pre-dose at Week 12 | PK Analysis Set China (PK CHN) included all participants \>=12 years to \<18 years who were treated with macitentan, for whom a PK blood sample has been taken and who did not deviate from the protocol in a way that might affect the evaluation of the PK endpoints. | ng/mL | MEAN |
| SECONDARY | Time to the First Clinical Event Committee (CEC)-Confirmed Disease Progression Event | Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) | |||
| SECONDARY | Time to First CEC-confirmed Hospitalization for PAH | Baseline (Day 1) up to EOCP (up to 7.08 years) | |||
| SECONDARY | Time to CEC-confirmed Death Due to PAH | Baseline (Day 1) up to EOCP (up to 7.08 years) | |||
| SECONDARY | Time to Death (All Causes) | Baseline (Day 1) up to 7.26 years | |||
| SECONDARY | Percentage of Participants With World Health Organization (WHO) Functional Class (FC) I or II Versus III or IV | At Weeks 12 and 24 | |||
| SECONDARY | Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) at Weeks 12 and 24 | Baseline (Day 1), Weeks 12 and 24 | |||
| SECONDARY | Change From Baseline in Mean Daily Time Spent in Moderate to Vigorous Physical Activity as Measured by Accelerometry at Week 48 | Baseline (Day 1), Week 48 | |||
| SECONDARY | Change From Baseline in Body Surface Area (BSA) Normalized Tricuspid Annular Plane Systolic Excursion (TAPSE) Measured by Echocardiography at Week 24 | Baseline (Day 1), Week 24 | |||
| SECONDARY | Change From Baseline in Left Ventricular Eccentricity Index (LVEI) Measured by Echocardiography at Week 24 | Baseline (Day 1), Week 24 | |||
| SECONDARY | Change From Baseline in Quality of Life Measured by Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0) Generic Core Scales Short Form (SF-15) | Baseline (Day 1), Week 24 | |||
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline (Day 1) up to 7.26 years | |||
| SECONDARY | Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | Baseline (Day 1) up to 7.26 years | |||
| SECONDARY | Number of Participants With AEs Leading to Premature Discontinuation of Macitentan or Standard of Care (SoC) | Baseline (Day 1) up to 7.26 years | |||
| SECONDARY | Number of Participants With AEs of Special Interest | Baseline (Day 1) up to 7.26 years | |||
| SECONDARY | Number of Participants With Marked Laboratory Abnormalities | Baseline (Day 1) up to 7.26 years | |||
| SECONDARY | Change From Baseline in Selected Laboratory Parameters | Baseline (Day 1) up to 7.26 years |
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
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GET https://conductscience.org/api/trials/v1/NCT02932410/outcomes