Trial · NCT04712669
A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (Core OLE)
NCT04712669, Phase 2, Completed, Altavant Sciences GmbH; results first posted 2025-06-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (Core OLE). Trials, record NCT04712669. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04712669
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (Core OLE)
- NCT number
- NCT04712669
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 108 participants, actual
- Lead sponsor
- Altavant Sciences GmbH
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- rodatristat ethyl 300 mg tablet BID, rodatristat ethyl 600 mg BID, Placebo
- First posted
- 2021-01-15
- Last updated
- 2025-06-04
- Results first posted
- 2025-06-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline of Pulmonary Vascular Resistance (PVR) at Week 24 | 24 Weeks | Pulmonary vascular resistance (PVR) was measured by right heart catheterization (RHC) |
| Secondary | Change From Baseline in World Health Organization (WHO) Functional Class (FC) | 24 Weeks | PAH functional disease severity is classified in 4 classes (I to IV) according to World Health Organization (WHO). I:Patients with pulmonary hypertension (PH) but without resulting limitation of physical act.Ordinary physical act does not cause undue dyspnea,fatigue,chest pain,near syncope. II:Patients with PH with slight limitation of physical act.Ordinary physical act causes undue dyspnea or fatigue, chest pain,or near syncope. III:Patients with PH with marked limitation of physical act.Less than ordinary act causes undue dyspnea or fatigue,chest pain,or near syncope. IV:Patients with PH with inability to carry out any physical act without symptoms,manifest signs of right-heart failure.Dyspnea and/or fatigue may even be present at rest.Discomfort is increased by physical act -II, -I:Patients condition improved at WK24 compared with baseline II, I:Patients condition worsened at WK24 compared with baseline No change:Patients condition not changes at WK24 compare with baseline |
| Secondary | Change From Baseline in Six-minute Walk Distance (6MWD) | 24 Weeks | The six-minute walk distance (6MWD) is a simple, commonly used, standardized measure of functional exercise capacity and endurance. It is a commonly used measure of efficacy in PAH clinical studies. |
| Secondary | Change From Baseline in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Levels | 24 Weeks | N-terminal prohormone of brain natriuretic peptide (NT-proBNP) is a strong predictor of disease progression and mortality in PAH patients. Current PAH treatment guidelines recommend measurement of NT-proBNP levels for both risk assessment and longitudinal follow up. NT-proBNP levels are also a good marker of response to treatment. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline of Pulmonary Vascular Resistance (PVR) at Week 24 | 24 Weeks | ITT population | percent | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in World Health Organization (WHO) Functional Class (FC) | 24 Weeks | ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Six-minute Walk Distance (6MWD) | 24 Weeks | ITT population | six-minute walk distance (6MWD) (meters) | MEDIAN |
| SECONDARY | Change From Baseline in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Levels | 24 Weeks | ITT population | pg/mL | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline of Pulmonary Vascular Resistance (PVR) at Week 24 | Rodatristat Ethyl 300 mg BID | 63.083 | Standard Error 18.529 | percent | |
| Percent Change From Baseline of Pulmonary Vascular Resistance (PVR) at Week 24 | Rodatristat Ethyl 600 mg BID | 64.219 | Standard Error 18.013 | percent | |
| Percent Change From Baseline of Pulmonary Vascular Resistance (PVR) at Week 24 | Placebo | 5.813 | Standard Error 18.052 | percent | |
| Change From Baseline in World Health Organization (WHO) Functional Class (FC) | Rodatristat Ethyl 300 mg BID | -II | 0 | Participants | |
| Change From Baseline in World Health Organization (WHO) Functional Class (FC) | Rodatristat Ethyl 600 mg BID | -II | 0 | Participants | |
| Change From Baseline in World Health Organization (WHO) Functional Class (FC) | Placebo | -II | 0 | Participants | |
| Change From Baseline in World Health Organization (WHO) Functional Class (FC) | Rodatristat Ethyl 300 mg BID | -I | 2 | Participants | |
| Change From Baseline in World Health Organization (WHO) Functional Class (FC) | Rodatristat Ethyl 600 mg BID | -I | 3 | Participants | |
| Change From Baseline in World Health Organization (WHO) Functional Class (FC) | Placebo | -I | 3 | Participants | |
| Change From Baseline in World Health Organization (WHO) Functional Class (FC) | Rodatristat Ethyl 300 mg BID | No Change | 30 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind Phase | STARTED | Rodatristat Ethyl 300 mg BID | 36 | |
| Double Blind Phase | STARTED | Rodatristat Ethyl 600 mg BID | 36 | |
| Double Blind Phase | STARTED | Placebo | 36 | |
| Double Blind Phase | STARTED | Placebo-Rodatristat Ethyl 300 mg | 0 | |
| Double Blind Phase | STARTED | Placebo-Rodatristat Ethyl 600 mg | 0 | |
| Double Blind Phase | STARTED | Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 300 mg | 0 | |
| Double Blind Phase | STARTED | Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 600 mg | 0 | |
| Double Blind Phase | STARTED | Rodatristat Ethyl 600 Mg-Rodatristat Ethyl 600 mg | 0 | |
| Double Blind Phase | COMPLETED | Rodatristat Ethyl 300 mg BID | 28 | |
| Double Blind Phase | COMPLETED | Rodatristat Ethyl 600 mg BID | 26 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events1,168
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Rodatristat Ethyl 300 mg BID | 5 | 36 | 5 |
| other | COVID-19 | Infections and infestations | Rodatristat Ethyl 600 mg BID | 3 | 36 | 3 |
| other | COVID-19 | Infections and infestations | Placebo | 8 | 36 | 8 |
| other | COVID-19 | Infections and infestations | Placebo-Rodatristat Ethyl 300 mg | 3 | 15 | 5 |
| other | COVID-19 | Infections and infestations | Placebo-Rodatristat Ethyl 600 mg | 7 | 16 | 8 |
| other | COVID-19 | Infections and infestations | Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 300 mg | 5 | 22 | 5 |
| other | COVID-19 | Infections and infestations | Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 600 mg | 1 | 2 | 1 |
| other | COVID-19 | Infections and infestations | Rodatristat Ethyl 600 Mg-Rodatristat Ethyl 600 mg | 6 | 21 | 6 |
| other | Nasopharyngitis | Infections and infestations | Rodatristat Ethyl 300 mg BID | 1 | 36 | 1 |
| other | Nasopharyngitis | Infections and infestations | Rodatristat Ethyl 600 mg BID | 2 | 36 | 2 |
1 to 10 of 1,168Source ClinicalTrials.gov
See all 1,168 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rodatristat Ethyl 300 mg BID | 1 | 36 |
| Total, all-cause mortality | Rodatristat Ethyl 600 mg BID | 0 | 36 |
| Total, all-cause mortality | Placebo | 0 | 36 |
| Total, all-cause mortality | Placebo-Rodatristat Ethyl 300 mg | 2 | 15 |
| Total, all-cause mortality | Placebo-Rodatristat Ethyl 600 mg | 0 | 16 |
| Total, all-cause mortality | Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 300 mg | 0 | 22 |
| Total, all-cause mortality | Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 600 mg | 0 | 2 |
| Total, all-cause mortality | Rodatristat Ethyl 600 Mg-Rodatristat Ethyl 600 mg | 0 | 21 |
| Total, other adverse events | Rodatristat Ethyl 300 mg BID | 32 | 36 |
| Total, other adverse events | Rodatristat Ethyl 600 mg BID | 34 | 36 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT04712669
GET https://conductscience.org/api/trials/v1/NCT04712669/results?page=2