In short
Clinical trials are studying ROC-101 HYDROCHLORIDE in people with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. These trials aim to check safety, tolerability, and whether the treatment can improve pulmonary vascular resistance. The study includes adults treated with standard care.
Key points
- Clinical trials of ROC-101 HYDROCHLORIDE are studying people with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. The main trial is a Phase 2 interventional study with 40 planned participants. Researchers are looking at change in pulmonary vascular resistance after 24 weeks. The study also measures safety through adverse events, vital signs, ECGs, and laboratory tests. Participants receive ROC-101 HYDROCHLORIDE plus standard of care.
Trial overview
The main study of ROC-101 HYDROCHLORIDE is titled the ROCSTAR Study and is listed as authorised. It is an interventional trial, which means researchers give the study treatment and then measure the results.
The study plans to enroll 40 participants and is being done in Phase 2. The trial uses oral ROC-101 HYDROCHLORIDE at 40 mg and includes standard of care treatment.
Conditions and population
This trial is studying two lung-related conditions: pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (ILD-PH). Both conditions involve high pressure in the blood vessels of the lungs, which can make it harder for the heart and lungs to work well.
The study summary says the participants are treated with ROC-101 HYDROCHLORIDE plus standard of care. No other eligibility details are provided in the source data.
Study design and phase
This is a Phase 2 study, which usually means the treatment has already been tested enough to move into a larger group and look more closely at possible benefit and safety. The trial is interventional rather than observational, so the research team is actively testing the treatment effect.
The study is authorised, which means it has received permission to move forward.
What the study measures
The main effectiveness measure is the change in pulmonary vascular resistance (PVR) from the start of the study to 24 weeks. PVR is a measure of how hard it is for blood to flow through the lung blood vessels.
The study also checks safety and tolerability, including adverse events, which are unwanted medical problems that happen during the trial. Other safety measures include vital signs, 12-lead ECGs, and safety laboratory tests.
Safety monitoring
The trial lists several safety checks: body temperature, heart rate, blood pressure, respiratory rate, fraction of inspired oxygen, and oxygen saturation. These checks help the study team watch for changes in the body during treatment.
The study also includes 12-lead electrocardiograms (ECG) and safety laboratory tests. An ECG is a heart test that records electrical activity, and laboratory tests can help show whether treatment is affecting the body in unexpected ways.
What this means for patients
For patients, this study is mainly asking whether ROC-101 HYDROCHLORIDE can be used safely in people with PAH or ILD-PH and whether it may help improve blood flow resistance in the lungs. Because it is a Phase 2 study, it is still part of clinical research and is not yet a final answer about how well the treatment works.
The source data does not give a long list of inclusion or exclusion rules, so only the broad target groups can be described from the trial record. The most important details are the condition studied, the 40-person size, the 24-week main endpoint, and the safety monitoring plan.