A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse.

Sotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH.

This is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.

Eligibility criteria

Qualifiers

Has completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early

Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements

Must have the ability to understand and provide documented informed consent

Disqualifiers

Did not participate in a sotatercept PAH parent study

Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.

Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept

Is a female who is pregnant or breastfeeding

Trial design

Treatments tested in this trial

  • Sotatercept

Treatment groups

815 Participants
are divided into 1 treatment group

Sponsors and collaborators