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SELECT: SELExipag in inoperable or persistent/recurrent Chronic Thromboembolic pulmonary hypertension: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension.
Description
This is a 52 week blinded study in which the subject would recieve either Selexipag or Pacebo. Study visits are approximately every 6 to 12 weeks and study participants may be eligible for the open label extension at the end of 52 weeks.
MoreDetails
Age
Adult
Eligibility
1) Men or Women 18-85 years of age 2) Must have a diagnosis of CTEPH and be considered either inoperable or have persistant CTEPH after either PEA or BPA 3) Must have had a right heart cath in the last 90 days or be willing to have ot repeated. The RHC must show a mPAP of at least 25 mmHg, PVR at least 5 wu and a PAWP no more than 15 mmHg. 4) Must be able to perform a 6 minute walk test 5) Must not be pregnant and be willing to use birth control during the study 6) must be stable on prescribed medications, including PH medications for 90 days prior to visit 2 7) Patient cannot be currently treated with epoprostinil, treprostinil, iloprost, beraprost, selexipag within 90 days of Visit 2.
Phase
III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
Type of Study
Treatment
Location
University of Colorado Hospital
Principal Investigator
Todd Bull, MD
Study ID
Protocol Number: 19-0347
More information available at ClinicalTrials.gov: NCT03689244
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