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NCT06475781
Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD (Windward)
Conditions: Group 3 Pulmonary Hypertension
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 126
Sponsor: Foresee Pharmaceuticals Co., Ltd.
Location: University Clinical Centre of the Republic of Srpska Banja Luka
Summary
The goal of this clinical trial is to see if mirivadelgat will work in participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD). It will also learn about the safety of mirivadelgat. The main question it aims to answer is if mirivadelgat will improve pulmonary vascular resistance (PVR). Pulmonary vascular resistance is a way to measure blood flow in the lungs.
Researchers will compare mirivadelgat to a placebo (a look-alike capsule that contains no drug) to see if mirivadelgat works to improve the symptoms of PH-ILD. The symptoms of PH-ILD that are being looked at are exercise tolerance, heart function, and general well-being.
Participants will:
Take mirivadelgat or a placebo once a day for 12 weeks
Visit the clinic once every 4 weeks for checkups and tests
Receive phone calls every one or two weeks to check on how things are going
Eligibility Criteria
Inclusion Criteria:
1. A clinical diagnosis of PH-ILD.
2. Participant voluntarily gives informed consent.
3. Male or female participants aged between 18 and 85 years at the time of signing informed consent.
4. Participants must agree to practice protocol-defined birth control during the study period, unless they meet criteria for not being of childbearing potential.
* Male participants with female partners of childbearing potential must practice protocol- defined birth control for the duration of treatment and at least 96 hours after discontinuing the IP.
* Female participants of childbearing of potential (including those \
Source: ClinicalTrials.gov (NCT06475781). StuddyBuddy aggregates publicly available trial information.