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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • CS1

    Drug

    160 mg delayed release capsules taken orally once daily in the evening

  • Placebo

    Drug

    Matching placebo capsules taken orally once daily in the evening

Treatment groups

126 Participants
are divided into 3 treatment groups
Group A: CS1 320 mgExperimental treatment 2 interventions
Group B: CS1 640 mgExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in pulmonary vascular resistance (PVR)

Pulmonary vascular resistance calculated from right heart catheterization measurements using the Thermodilution or Fick method for determination of cardiac output.

Time frame
Baseline to Week 36

Secondary outcomes

1

Change from baseline in 6-minute walk distance (6MWD)

Time frame
Baseline to Week 36
2

Change from baseline in Registry to Evaluate Early and Long-term Pulmonary Arterial Hypertension Disease Management (REVEAL) Lite 2 score

Time frame
Baseline to Week 36
3

Change from baseline in REVEAL Risk Score (RRS) 2.0

Time frame
Baseline to Week 36
4

Change from baseline in tricuspid annular plane systolic excursion (TAPSE)

Time frame
Baseline to Week 36

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cereno Scientific AB

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: