Phase 2
Completed N=108
A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (Core OLE)
Source: ClinicalTrials.gov NCT04712669 ↗Enrolled (actual)
108
Serious AEs
16.9%
Results posted
Jun 2025
Primary outcomePrimary: Percent Change From Baseline of Pulmonary Vascular Resistance (PVR) at Week 24 — 63.083; 64.219; 5.813 percent — p=0.0208
Summary
The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline of Pulmonary Vascular Resistance (PVR) at Week 24 |
63.083; 64.219; 5.813 | 0.0208 sig |
| SECONDARY Change From Baseline in World Health Organization (WHO) Functional Class (FC) |
0; 0; 0; 2; 3; 3 | 0.573 |
| SECONDARY Change From Baseline in Six-minute Walk Distance (6MWD) |
-14.5; 0; 2.5 | 0.0636 |
| SECONDARY Change From Baseline in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Levels |
1145.7; 886.1; 19.8 | 0.0014 sig |
Eligibility Criteria
Inclusion Criteria
- Male and female 18 years or older 2. Body Mass Index (BMI) >18kg/m2 to 20 mmHg
- PVR ≥ 350 dyne•sec/cm5
- Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) of ≤ 12 mmHg if PVR ≥ 350 and 15 mmHg), pulmonary capillary hemangiomatosis, portal hypertension, or unrepaired congenital heart defects (CHD)
- Three or more of the following risk factors for left ventricular disease:
- BMI > 30 kg/m2
- Diagnosis of essential hypertension that is actively treated
- Diabetes mellitus
- History of significant coronary artery disease (e.g., chronic stable angina, history of coronary intervention within the last 3 months, or a stenosis > 70% at coronary angiography)
- Atrial fibrillation
- Left atrial volume index > 41 mL/m2 [or left atrial diameter (LA) > 4 cm if LAVi unavailable]
- Known genetic hypertrophic cardiomyopathy
- Known cardiac sarcoidosis or amyloidosis
- The patient has a history of, or currently has, a constrictive cardiomyopathy.
- Known history of any left ventricular ejection fraction (LVEF) Grade 3)
- Severe arthritis, musculoskeletal problems, or morbid obesity that, in the opinion of the Investigator, is the cause of the patient's functional limitation and would affect the patient's ability to perform or complete the 6MWT.
Data sourced from ClinicalTrials.gov (NCT04712669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.