Trial · NCT05731492
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Trough Concentration of Macitentan and its Active Metabolite Aprocitentan at Week 4 in Steady-State | Predose (at Week 4) | Trough concentration of macitentan and its active metabolite aprocitentan at week 4 in steady-state will be reported. |
| Secondary | Number of Participants with Adverse Events (AEs) | Up to 1.5 years | 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. |
| Secondary | Number of Participants with Serious Adverse Events (SAEs) | Up to 1.5 years | 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. |
| Secondary | Number of Participants with AEs Leading to Premature Discontinuation of Macitentan | Up to 1.5 years | Number of participants with AEs Leading to premature discontinuation of macitentan will be reported. |
| Secondary | Number of Participants with Adverse Event of Special Interests (AESIs) | Up to 1.5 years | 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. |
| Secondary | Number of Participants with Clinical Laboratory Abnormalities | Up to 1.5 years | Number of participants with clinical laboratory abnormalities (serum, chemistry and hematology) will be reported. |
| Secondary | Number of Participants with Change from Baseline in Clinical laboratory Values. | Up to 1.5 years | Number of participants with change from baseline in clinical laboratory values will be reported. |
| Secondary | Change from Baseline in Blood Pressure | Up to 1.5 years | Change from baseline in blood pressure will be reported. |
| Secondary | Change From Baseline in Heart Rate | Up to 1.5 years | Change from baseline in heart rate will be reported. |
| Secondary | Change From Baseline in Body Weight | Up to 1.5 years | Change from baseline in body weight will be reported. |
| Secondary | Change From Baseline in Length | Up to 1.5 years | Change from baseline in length will be reported. |
| Secondary | Change from Baseline in Height | Up to 1.5 years | Change from baseline in height will be reported. |
| Secondary | Plasma Concentration of Macitentan and its Active Metabolite (Aprocitentan) for Macitentan Naive Participants | At 2, 5, and 24 hours after the first dose of macitentan on Day 1 | Plasma concentrations of macitentan and its active metabolite (aprocitentan) after the first dose of macitentan for macitentan naive participants will be reported. |
| Secondary | Trough Concentrations of Macitentan and its Active Metabolite Aprocitentan at Week 8 in Steady-State Conditions | Predose (at Week 8) | Trough concentrations of macitentan and its active metabolite aprocitentan at week 8 in steady-state conditions will be 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.govNone 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.
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GET https://conductscience.org/api/trials/v1/NCT05731492/registered