Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)

Condition(s) studied

Investigational drug(s) / intervention(s)

Sotatercept: subcutaneous injection

Study summary

Researchers are looking for new ways to treat people with a type of pulmonary hypertension called combined postcapillary and precapillary pulmonary hypertension (Cpc-PH). This study focuses on Cpc-PH that is caused by heart failure with preserved ejection fraction (HFpEF).

Researchers want to know if the study treatment, sotatercept, can treat people with Cpc-PH caused by HFpEF. This is an extension study, which means people who took part in a certain study on sotatercept for Cpc-PH (called a parent study) may be able to join this study. In this extension study, people will take sotatercept and researchers will follow their health for a longer time.

The main goal of this extension study is to learn about the long-term safety of sotatercept and if people tolerate it over a longer period of time.

Eligibility

Primary outcome measure(s)

• Number of Participants Who Experience an Adverse Event (AE) — Up to approximately 10 years
  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
• Number of Participants Who Discontinue Study Treatment Due to an AE — Up to approximately 10 years
  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

Trial sites (57)

+ 17 more sites — see the full list on the official registry below.