Trial · NCT06603285
A Study to Observe the Safety, Tolerability, and Efficacy of Remodulin
NCT06603285, Not yet recruiting, Excelsior
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Observe the Safety, Tolerability, and Efficacy of Remodulin. Trials, record NCT06603285. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06603285
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Observe the Safety, Tolerability, and Efficacy of Remodulin
- NCT number
- NCT06603285
- Status
- Not yet recruiting
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Excelsior
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Treprostinil
- First posted
- 2024-09-19
- Last updated
- 2025-08-15
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in NT-proBNP | Week 97 | Calculate the \"N terminal pro B type natriuretic peptide\" change from baseline to Week 97 |
| Primary | Change from baseline in WHO functional class | Week 97 | Calculate the World Health Organization functional class change from baseline to Week 97. The World Health Organization (WHO) functional class describes how severe a patient\'s pulmonary hypertension (PH) symptoms are. There are four different classes - I is the mildest and IV is the most severe form of PH. |
| Secondary | Time to clinical worsening and death | 96 weeks | Record the time to clinical worsening and death |
| Secondary | Change from baseline in NT-proBNP | Week 13, 25, 37, 49, 61, 73, and 85 | Calculate the change from baseline in NT-proBNP at Week 13, 25, 37, 49, 61, 73, and 85 |
| Secondary | Change from baseline in 6-minute walk distance (6MWD) | Week 25, 49, 73, and 97 | Calculate the cange from baseline in 6-minute walk distance (6MWD) at Week 25, 49, 73, and 97 |
| Secondary | Trend of dose usage from initiation treatment to clinical worsening | 96 weeks | Record all the daily doses which the patients administered during the whole study period |
| Secondary | Adverse events of special interest (AESIs) | 96 weeks | AESIs include infusion site pain, infusion site reaction, headache, diarrhea, nausea, rash, jaw pain, hot flashes, vasodilation, and edema |
| Secondary | Change from baseline in WHO functional class | Week 13, 25, 37, 49, 61, 73, and 85 | Calculate the change from baseline in WHO functional class at Week 13, 25, 37, 49, 61, 73, and 85 The World Health Organization (WHO) functional class describes how severe a patient\'s pulmonary hypertension (PH) symptoms are. There are four different classes - I is the mildest and IV is the most severe form of PH. |
| Secondary | Change from baseline in right atrium (RA) area | Week 25, 49, 73, and 97 | RV structure and function will be monitored by echocardiography, including Right atrium (RA) area. |
| Secondary | Change from baseline in TAPSE/sPAP ratio. | Week 25, 49, 73, and 97 | RV structure and function will be monitored by echocardiography, including Tricuspid annular plane systolic excursion (TAPSE) / systolic pulmonary artery pressure (sPAP) ratio. |
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.
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/NCT06603285
GET https://conductscience.org/api/trials/v1/NCT06603285/registered