Trial · NCT05731492
A Study of Macitentan in Children Below 2 Years of Age
NCT05731492, Phase 1, Withdrawn, Actelion
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of Macitentan in Children Below 2 Years of Age. Trials, record NCT05731492. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05731492
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Macitentan in Children Below 2 Years of Age
- NCT number
- NCT05731492
- Status
- Withdrawn
- Phases
- Phase 1
- Enrollment
- 0 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Arterial Hypertension, Pulmonary
- Interventions
- Macitentan
- First posted
- 2023-02-16
- Last updated
- 2025-03-30
- Other registries' IDs
- eudract:2022-002754-74
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05731492
GET https://conductscience.org/api/trials/v1/NCT05731492/registered