Loading clinical trials...

A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment | Clinical Trials | Clareo Health

TERMINATEDPHASE3

A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment

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

NCT03689244•Actelion

View on ClinicalTrials.gov

Summary

Selexipag is available in many countries for the treatment of pulmonary arterial hypertension (PAH). Due to the similarities between PAH and chronic thromboembolic pulmonary hypertension (CTEPH) and the observed efficacy of other PAH medicines in CTEPH, it is believed that selexipag could benefit to patients with CTEPH. This study aims to assess the efficacy and safety of selexipag in participants with inoperable or persistent/recurrent CTEPH.

Detailed Description

Participants will be recruited in two sequential cohorts: approximately the first 90 randomized participants will undergo a right heart catheterization (RHC) (and left heart catheterization LHC, if needed) with measurement of pulmonary vascular resistance (PVR) at Week 20 and will constitute the hemodynamic cohort; the remaining participants will constitute the non-hemodynamic cohort; who do not require a post-baseline hemodynamic assessment. They will undergo the same overall study assessments as the hemodynamic cohort excepted for RHC at Week 20.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed and dated informed consent form
•Male and female participants from greater than or equal to (\>) 18 (or the legal age of consent in the jurisdiction in which the study is taking place) and less then or equal to (\<=85) years old at Screening (Visit 1)
•With established diagnosis of inoperable CTEPH (i.e., technically non-operable) or persistent/recurrent CTEPH after pulmonary endarterectomy (PEA) and/or balloon pulmonary angioplasty (BPA), as confirmed by the corresponding adjudication committee
•With pulmonary hypertension (PH) in WHO FC I-IV.
•Participant able to perform the 6-minute walk test (6MWT) with a minimum distance of 100 m and a maximum distance of 450 m at screening visit.
•Women of childbearing potential must have a negative pregnancy test at screening and randomization and must agree to undertake monthly urine pregnancy tests, and to use a reliable method of birth control from screening visit up to at least 30 days after study treatment discontinuation. If a hormonal contraceptive is chosen it must be taken for at least 1 month prior to randomization.

Exclusion Criteria

•Planned or current treatment with another investigational treatment up to 3 months prior to randomization.
•Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
•Known concomitant life-threatening disease with a life expectancy \< 12 months.
•Planned balloon pulmonary angioplasty within 26 weeks after randomization.
•Change in dose or initiation of new PH-specific therapy within 90 days prior to the baseline RHC (and LHC, if needed) qualifying for enrollment for the hemodynamic cohort and within 90 days prior to randomization (Visit 2) for the non-hemodynamic cohort
•Treatment with prostacyclin (epoprostenol), prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) or prostacyclin receptor agonists (i.e., selexipag) within 90 days prior to randomization (visit 2) except those given at vasodilator testing during RHC
•Change in dose or initiation of new diuretics and/or calcium channel blockers within 1 week prior to baseline RHC (and LHC, if needed)
•Any co-morbid condition that may influence the ability to perform a reliable and reproducible 6MWT, including use of walking aids (cane, walker, etc).
•Any other criteria as per selexipag Summary of Product Characteristics (SmPC).

Locations (162)

University of California San Diego Medical Center

La Jolla, California, United States

University of Southern California, Keck School of Medicine

Los Angeles, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Colorado Springs Pulmonary Consultants

Colorado Springs, Colorado, United States

South Denver Cardiology Associates PC

Littleton, Colorado, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Piedmont Healthcare

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

University of Chicago Hospitals - Chicago

Chicago, Illinois, United States

Key Dates

Start Date

January 23, 2019

Primary Completion Date

June 7, 2022

Completion Date

June 7, 2022

Last Updated

June 21, 2024

Enrollment

128

ACTUAL participants

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Interventions

Selexipag

DRUG

Placebo

DRUG

Chinese PE Multimodality Imaging Artificial Intelligence Study

NCT06526468

Pulmonary EmbolismChronic Thromboembolic Pulmonary Hypertension+1 more

View study

RECRUITING

Safety and Efficacy of Balloon Pulmonary Angioplasty in China

NCT04206852

Chronic Thromboembolic Pulmonary Hypertension

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment

Inclusion Criteria

Exclusion Criteria

Chinese PE Multimodality Imaging Artificial Intelligence Study

Safety and Efficacy of Balloon Pulmonary Angioplasty in China

Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension

What is the Role of the Exposome in Pulmonary Hypertension

Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD)

Inspiratory Muscle Training in Pulmonary Hypertension