Trial · NCT04915300
Apabetalone for Pulmonary Arterial Hypertension
NCT04915300, Phase 2, Unknown, Laval University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Apabetalone for Pulmonary Arterial Hypertension. Trials, record NCT04915300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04915300
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Apabetalone for Pulmonary Arterial Hypertension
- NCT number
- NCT04915300
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 72 participants, estimated
- Lead sponsor
- Laval University
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Apabetalone, Placebo
- First posted
- 2021-06-07
- Last updated
- 2023-04-18
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Placebo-corrected change from baseline in PVR at week 24 | Baseline, and 24 weeks later | Right heart catheterization: Measuring PVR is performed in a standardized manner in catheterization laboratories of the participating centres, according to recommendations. Printed copies of waveforms will be kept for monitoring visits and documentation of the accuracy of the pressures and calculations. |
| Secondary | Changes at week 24 in 6MWD | Baseline, week 8 and week 24 | The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. |
| Secondary | Changes at week 24 in plasma NT-proBNP concentration | Baseline, week 8 and week 24 | |
| Secondary | Changes at week 24 in WHO functional class | Baseline, week 8 and week 24 | There are four functional classes that are used to rate how ill PH patients are. Class I: No symptoms of pulmonary arterial hypertension with exercise or at rest. Class II: No symptoms at rest but uncomfortable and short of breath with normal activity such as climbing a flight of stairs, grocery shopping, or making the bed. Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. Class IV: Symptoms at rest and severe symptoms with any activity. |
| Secondary | Changes at week 24 in European Respiratory Society (ERS)/European Society of Cardiology (ESC) risk stratification score | Screening and Week 24 | The ERS/ESC risk stratification strategy will be used to categorize patients as low, intermediate or high risk. The cut-off values proposed in the guidelines will be graded 1-3 (1: low-, 2: intermediate- and 3: high-risk). For each patient, the sum of all grades will be divided by the number of variables and rounded to the next integer to define the risk group. The number of low-risk criteria per patients will also be assessed. |
| Secondary | Change at week 24 in mean Pulmonary Artery Pressure (mPAP), mmHg obtained from right heart catheterization | Screening and Week 24 | The hemodynamic definition of pulmonary arterial hypertension (PAH) is a mean pulmonary artery pressure at rest greater than or equal to 25 mmHg in the presence of a pulmonary capillary wedge pressure less than or equal to 15 mmHg. These measurements can only be taken accurately during a right heart catheterization. |
| Secondary | Change in cardiac output (L/min) | Screening and Week 24 | Catheterization |
| Secondary | Change in right atrial pressure (RAP), mmHg | Screening and Week 24 | Catheterization |
| Secondary | Change in mixed venous oxygen saturation (SvO2), % | Screening and Week 24 | Catheterization |
| Secondary | Change at week 24 in HRQoL assessed using the EmPHasis-10 questionnaire | Screening and Week 24 | The Emphasis-10 questionnaire is a short questionnaire for assessing HRQoL in pulmonary arterial hypertension. It has excellent measurement properties and is sensitive to differences in relevant clinical parameters. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT04915300
GET https://conductscience.org/api/trials/v1/NCT04915300/registered