Trial · NCT06968962
Comparison of Sequential to Initial Combination Therapy in PAH
NCT06968962, Not applicable, Recruiting, Second Affiliated Hospital, Zhejiang University, School of Medicine
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Comparison of Sequential to Initial Combination Therapy in PAH. Trials, record NCT06968962. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06968962
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Sequential to Initial Combination Therapy in PAH
- NCT number
- NCT06968962
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 376 participants, estimated
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Interventions
- Tadalafil, Ambrisentan, Ambrisentan mimic, Tadalafil mimic
- First posted
- 2025-05-13
- Last updated
- 2025-07-29
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The change of 6MWD at month 12 from baseline | Baseline and Month 12 | The 6MWD was the distance walked in 6 minutes as a measure of functional capacity. This was assessed using the 6-minute walk test (6MWT). |
| Secondary | Time to clinical failure events during the 12-month treatment period. | During the 12-month treatment period | Definition of Clinical Failure Events: 1. Death (all-cause) 2. Hospitalization due to worsening PAH (adjudicated) 1. Any hospitalization for worsening 2. PAH Lung or heart/lung transplantation 3. Atrial septostomy 4. Initiation of parenteral prostanoid therapy 5. Need to initiate rescue therapy <!-- --> 1. Switch Tadalafil to Macitentan 2. Add Selexipag 3. Add Sotatercept 3. Disease progression (adjudicated) 1. Decrease in 6MWD of more than 15% from baseline 2. Concurrent presence of WHO functional class III or IV symptoms (continuously observed in follow-up after baseline with at least 14 days apart) 4. Unsatisfactory long-term clinical response (Adjudicated, all criteria must be met) 1. Receiving at least one dose of randomized treatment and being in the study for at least 6 months 2. A decrease in 6MWD from baseline in two assessments separated by at least 14 days 3. WHO functional class III symptoms assessed at two visits separated by \> 6 months |
| Secondary | Low-risk status achievement rates. | Month 4, 8 and 12 | Risk stratification will be assess according to COMPERA 2.0, which includes WHO functional class, 6MWD, and BNP or NT-proBNP. |
| Secondary | The change of NT-proBNP at month 12 from baseline | Baseline and Month 12 | NT-proBNP is a circulating biomarker that reflects cardiac afterload, this will be measured by central lab. |
| Secondary | The change of WHO functional class at month 12 from baseline | Baseline and Month 12 | WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). |
| Secondary | The change of pulmonary vascular resistance at month 12 from baseline | Baseline and Month 12 | Pulmonary vascular resistance is a hemodynamic variable of pulmonary circulation and was measured by right heart catheterization. |
| Secondary | Percentage of subjects receiving mono, dual or triple therapy | Month 4, 8, and 12 | |
| Secondary | Percentage of subjects with satisfactory clinical response | Month 8, and 12 | 1. An increase of 10% in 6MWD compared to baseline. 2. Improvement or maintenance of WHO class I or II symptoms. 3. No clinical failure events occurring during the study. |
| Secondary | The change of EmPHasis-10 score from baseline | Baseline, Month 4, 8, and 12 | The EmPHasis-10 questionnaire is used during clinical assessments to estimate how pulmonary hypertension affects patients' life (range: 0=no impact to 5=severe impact). A higher score indicated more severe impact. |
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.
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/NCT06968962
GET https://conductscience.org/api/trials/v1/NCT06968962/registered