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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002754-74 | EudraCT Number | ||
| 67896062PAH1013 | Other Identifier | Actelion Pharmaceuticals Ltd |
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Sponsor Decision
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The purpose of this study is to learn what happens to macitentan and its active metabolite (aprocitentan) in the body of children aged between 1 month and 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label Core Treatment Period: Macitentan | Experimental | Participants will receive macitentan as a monotherapy or add-on to an existing therapy daily for 24 weeks during core treatment period. Optional treatment extension period of up to 1 year for those participants who completed the core treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macitentan | Drug | Macitentan will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Trough Concentration of Macitentan and its Active Metabolite Aprocitentan at Week 4 in Steady-State | Trough concentration of macitentan and its active metabolite aprocitentan at week 4 in steady-state will be reported. | Predose (at Week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Actelion Pharmaceuticals Ltd Clinical Trial | Actelion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitatsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany | |||
| Universitatsmedizin Gottingen |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C533860 | macitentan |
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| Up to 1.5 years |
| Number of Participants with Serious Adverse Events (SAEs) | A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product, is medically important. | Up to 1.5 years |
| Number of Participants with AEs Leading to Premature Discontinuation of Macitentan | Number of participants with AEs Leading to premature discontinuation of macitentan will be reported. | Up to 1.5 years |
| Number of Participants with Adverse Event of Special Interests (AESIs) | Number of participants with AESI will be reported. AEs considered to be of special interest are as hypotension, edema/fluid retention, hemoglobin decrease/anemia, liver events. | Up to 1.5 years |
| Number of Participants with Clinical Laboratory Abnormalities | Number of participants with clinical laboratory abnormalities (serum, chemistry and hematology) will be reported. | Up to 1.5 years |
| Number of Participants with Change from Baseline in Clinical laboratory Values. | Number of participants with change from baseline in clinical laboratory values will be reported. | Up to 1.5 years |
| Change from Baseline in Blood Pressure | Change from baseline in blood pressure will be reported. | Up to 1.5 years |
| Change From Baseline in Heart Rate | Change from baseline in heart rate will be reported. | Up to 1.5 years |
| Change From Baseline in Body Weight | Change from baseline in body weight will be reported. | Up to 1.5 years |
| Change From Baseline in Length | Change from baseline in length will be reported. | Up to 1.5 years |
| Change from Baseline in Height | Change from baseline in height will be reported. | Up to 1.5 years |
| Plasma Concentration of Macitentan and its Active Metabolite (Aprocitentan) for Macitentan Naive Participants | Plasma concentrations of macitentan and its active metabolite (aprocitentan) after the first dose of macitentan for macitentan naive participants will be reported. | At 2, 5, and 24 hours after the first dose of macitentan on Day 1 |
| Trough Concentrations of Macitentan and its Active Metabolite Aprocitentan at Week 8 in Steady-State Conditions | Trough concentrations of macitentan and its active metabolite aprocitentan at week 8 in steady-state conditions will be reported. | Predose (at Week 8) |
| Göttingen |
| 37075 |
| Germany |
| Instytut Pomnik Centrum Zdrowia Dziecka | Warsaw | 04 730 | Poland |
| Wojewodzki Szpital Specjalistyczny We Wroclawiu | Wroclaw | 51 124 | Poland |