CS1 Added to Standard of Care Therapy for Pulmonary Arterial Hypertension
ConditionPulmonary Arterial Hypertension
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCereno Scientific AB
About this trial
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
Qualifiers
Age 18 to 80 years
WHO Group 1 pulmonary arterial hypertension
WHO Functional Class II or III
REVEAL Lite 2 score ≥6
Disqualifiers
Pulmonary hypertension WHO Group 2, 3, 4, or 5
Significant left-sided heart disease
Recent major cardiovascular or cerebrovascular event
Prior heart or heart-lung transplantation or active lung transplant listing
Trial design
Treatments tested in this trial
- CS1
- Placebo
Treatment groups
126 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov