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NCT07761572
CS1 Added to Standard of Care Therapy for Pulmonary Arterial Hypertension
Conditions: Pulmonary Arterial Hypertension
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 126
Sponsor: Cereno Scientific AB
Summary
This Phase 2 study (EPIMODE) will evaluate the efficacy and safety of CS1 compared with placebo when added to standard-of-care therapy in participants with pulmonary arterial hypertension.
Participants completing Treatment Period 1 (Week 36) will be re-randomized to continue or switch study treatment for Treatment Period 2 through Week 52.
Eligibility Criteria
Inclusion Criteria:
* Age 18 to 80 years
* WHO Group 1 pulmonary arterial hypertension
* WHO Functional Class II or III
* REVEAL Lite 2 score ≥6
* Receiving stable standard-of-care PAH therapy for at least 90 days prior to screening
* Hemodynamic confirmation of PAH by right heart catheterization
* 6-minute walk distance ≥150 m and \
Source: ClinicalTrials.gov (NCT07761572). StuddyBuddy aggregates publicly available trial information.