Trial · NCT05437224
Efficacy and Safety Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension
NCT05437224, Phase 3, Completed, RenJi Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Efficacy and Safety Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension. Trials, record NCT05437224. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05437224
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension
- NCT number
- NCT05437224
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 80 participants, actual
- Lead sponsor
- RenJi Hospital
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Ambrisentan
- First posted
- 2022-06-29
- Last updated
- 2022-06-29
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to 12 weeks and 24weeks in 6-minute Walk Distance | Baseline, week 12 and week 24 | The 6-minute walk test (6MWT) is a non-encouraged test, performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. These guidelines were provided to all sites. For patients who had never performed a 6MWT previously, a training test was required before the qualifying tests for inclusion were performed. |
| Secondary | Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) up to Week 24, Assessed as the First Occurrence of a Clinical Worsening Events | From Baseline to week 24 | Clinical Worsening Events included a 15% decrease from baseline on the 6-minute walk test, hospitalization for pulmonary hypertension complications, dosing or escalation of pulmonary hypertension-targeted drugs, atrial septostomy, lung transplantation, or death. Time to clinical worsening of PAH is the time from baseline to the first clinical occurrence of a Clinical Worsening Events. |
| Secondary | Change from baseline to week 12 and 24 in Borg Dyspnea Index (BDI) sores | Baseline, week 12 and week 24 | The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum). |
| Secondary | Number of participants with a change from baseline to week 12 and 24 in WHO functional class | Baseline, week 12 and week 24 | The WHO FC was determined by the investigator as follows: Class I - Participants with pulmonary hypertension (PH) but without resulting limitation of physical activity; II- Participants with PH resulting in slight limitation of physical activity; III - Participants with PH resulting in marked limitation of physical activity; IV - Participants with PH with inability to carry out any physical activity without symptoms. |
| Secondary | Changes from baseline to week 12 and 24 in BNP plasma levels | Baseline, week 12 and week 24 | BNP is a surrogate maker of heart failure. |
| Secondary | Number and severity of Participants With Any Adverse Events | From Baseline to week 24 | An adverse event is defined as any adverse medical event in a patient that is not necessarily causally related to treatment. An adverse event can thus be any adverse or non-therapeutic sign (including abnormal laboratory results), symptom or disease temporally related to the use of the drug product, whether or not considered drug-related. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37378404 | DERIVED |
Source PubMed
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/NCT05437224
GET https://conductscience.org/api/trials/v1/NCT05437224/registered