Trial · NCT06814145
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 10 years | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported. |
| Primary | Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 10 years | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported. |
| Secondary | Change From Parent Study Baseline in Pulmonary Vascular Resistance (PVR) at 6 Months Following Enrollment in the Extension | Baseline and Month 6 | PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC). The change from baseline in PVR at Month 6 will be presented. Per protocol, baseline was defined as the baseline data collected for each participant at the time of their enrollment on one of the parent studies. |
| Secondary | Change From Baseline in the 6-Minute Walk Distance (6MWD) at 6 Months Following Enrollment in the Extension | Baseline and Month 6 | The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 6 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension. |
| Secondary | Change From Baseline in the 6MWD at 12 Months Following Enrollment in the Extension | Baseline and Month 12 | The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 12 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension. |
| Secondary | Change From Baseline in the 6MWD at 18 Months Following Enrollment in the Extension | Baseline and Month 18 | The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 18 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension. |
| Secondary | Change From Baseline in the 6MWD at End of Treatment | Baseline and up to approximately 43.5 months | The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at the time of treatment discontinuation will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension. |
| Secondary | Change From Baseline in New York Heart Association Functional Class (NYHA FC) at 6 Months Following Enrollment in the Extension | Baseline and Month 6 | NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 6 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension. |
| Secondary | Change From Baseline in NYHA FC at 12 Months Following Enrollment in the Extension | Baseline and Month 12 | NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 12 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension. |
| Secondary | Change From Baseline in NYHA FC at 18 Months Following Enrollment in the Extension | Baseline and Month 18 | NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 18 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension. |
| Secondary | Change From Baseline in NYHA FC at End of Treatment | Baseline and up to approximately 10 years | NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at the time of treatment discontinuation will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension. |
| Secondary | Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at 6 Months Following Enrollment in the Extension | Baseline and Month 6 | NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. The change from baseline in NT-proBNP at Month 6 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension. |
| Secondary | Change From Baseline in NT-proBNP at 12 Months Following Enrollment in the Extension | Baseline and Month 12 | NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. The change from baseline in NT-proBNP at Month 12 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension. |
| Secondary | Change From Baseline in NT-proBNP at 18 Months Following Enrollment in the Extension | Baseline and Month 18 | NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. The change from baseline in NT-proBNP at Month 18 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension. |
| Secondary | Change From Baseline in NT-proBNP at End of Treatment | Baseline and up to approximately 10 years | NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. The change from baseline in NT-proBNP at the time of treatment discontinuation will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension. |
| Secondary | Change From Parent Study Week 24 in PVR at 6 Months Following Enrollment in the Extension for Placebo Participants | Baseline and Month 6 | PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC). The change from parent study Week 24 in PVR at Month 6 will be presented. Per protocol, baseline was defined as the value collected at Week 24 of the parent study. |
| Secondary | Change From Baseline in 6MWD at 6 Months Following Enrollment in the Extension for Placebo Participants | Baseline and Month 6 | The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 6 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension. |
| Secondary | Change From Baseline in 6MWD at 12 Months Following Enrollment in the Extension for Placebo Participants | Baseline and Month 12 | The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 12 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension. |
| Secondary | Change From Baseline in 6MWD at 18 Months Following Enrollment in the Extension for Placebo Participants | Baseline and Month 18 | The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 18 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension. |
| Secondary | Change From Baseline in 6MWD at End of Treatment for Placebo Participants | Baseline and up to approximately 43.5 months | The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at the time of treatment discontinuation will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT06814145/registered