Trial · NCT04039464
Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension
NCT04039464, Phase 3, Completed, Johns Hopkins University
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension. Trials, record NCT04039464. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04039464
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension
- NCT number
- NCT04039464
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 28 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Pediatric Pulmonary Hypertension
- Interventions
- Mono-Therapy with Sildenafil, Duo-Therapy with Sildenafil + Bosentan
- First posted
- 2019-07-31
- Last updated
- 2026-02-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in WHO functional class (FC) of Mono vs. Dual Therapy | Baseline, 12 months | There are four WHO functional classes: Class I: Pulmonary hypertension without resulting limitation of physical activity; Ordinary physical activity does not cause undue dyspnea or fatigue, or chest pain or near-syncope; Class II: Pulmonary hypertension resulting in a slight limitation of physical activity; Comfortable at rest; Ordinary physical activity causes undue dyspnea or fatigue, or chest pain or near-syncope; Class III: Pulmonary hypertension resulting in a marked limitation of physical activity; Comfortable at rest; Less than ordinary physical activity causes undue dyspnea or fatigue, or chest pain or near-syncope; Class IV: Pulmonary hypertension resulting in inability to carry out any physical activity without symptoms; Signs of right heart failure; Marked limitation of physical activity; Dyspnea and/or fatigue may be present at rest; Discomfort. This will be an assessment of a change from one class to another per participant in each arm. |
| Secondary | Time to clinical worsening (TTCW) | 24 months | TTCW has become increasingly used in multicenter randomized clinical trials of adult pulmonary hypertension (PH) and will be used in this trial to capture time (in days) from study enrollment to clinical worsening. Disease progression will be defined as deterioration in WHO FC and the need for additional therapy for subjects less than 8 years of age. Subjects that are over 8 years old will follow adult criteria for this event - both deterioration in WHO FC and more than a 15% decrease in 6 minute walk distance (MWD) from baseline. TTCW is defined as a composite including disease progression, hospitalization for worsening PH, addition of other prostanoid drug therapies, Potts shunt, lung transplantation or atrial septostomy, and all-cause death. |
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.
Grants4
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U24TR004440 | Johns Hopkins University Trial Innovation Center | HANLEY, DANIEL F | JOHNS HOPKINS UNIVERSITY | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2023 to 2025 | NIH RePORTER |
| UH3HL151458 | 1/2 Kids MoD PAH Trial: Mono- vs. Duo-Therapy In Pediatric Pulmonary Arterial Hypertension | ROMER, LEWIS H; ABMAN, STEVEN HERBERT; BERMAN-ROSENZWEIG, ERIKA S. | JOHNS HOPKINS UNIVERSITY | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2023 to 2025 | NIH RePORTER |
| U24TR001609 | Johns Hopkins-Tufts Trial Innovation Center | HANLEY, DANIEL F | JOHNS HOPKINS UNIVERSITY | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2016 to 2022 | NIH RePORTER |
| UG3HL151458 | 1/2 Kids MoD PAH Trial: Mono- vs. Duo-Therapy In Pediatric Pulmonary Arterial Hypertension | ROMER, LEWIS H; ABMAN, STEVEN HERBERT; BERMAN-ROSENZWEIG, ERIKA S. | JOHNS HOPKINS UNIVERSITY | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2021 | NIH RePORTER |
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/NCT04039464
GET https://conductscience.org/api/trials/v1/NCT04039464/registered