Status:
RECRUITING
A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 lung...
Detailed Description
LTFU PAH sotatercept study MK-7962-004 (Obsolete Identifier: NCT04796337) has been incorporated into the current MK-7962-038 (NCT07218029) study for administrative reasons. The MK-7962-004 study is no...
Eligibility Criteria
Inclusion
- The main inclusion criteria include but are not limited to the following:
- 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
Exclusion
- The main exclusion criteria include but are not limited to the following:
- 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
- Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
- Is currently enrolled in another investigational product study other than a sotatercept study
- Is incapacitated
Key Trial Info
Start Date :
May 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 7 2028
Estimated Enrollment :
815 Patients enrolled
Trial Details
Trial ID
NCT07218029
Start Date
May 12 2021
End Date
December 7 2028
Last Update
December 18 2025
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Pulmonary Associates, PA ( Site 1008)
Phoenix, Arizona, United States, 85032
2
University of California San Diego Health ( Site 1002)
La Jolla, California, United States, 92039
3
University of Colorado Hospital ( Site 1013)
Aurora, Colorado, United States, 80045
4
Norton Pulmonary Specialists ( Site 1066)
Louisville, Kentucky, United States, 40202