Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03689244




Registration number
NCT03689244
Ethics application status
Date submitted
27/09/2018
Date registered
28/09/2018
Date last updated
21/06/2024

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
2018-002823-41
Secondary ID [2] 0 0
AC-065B302
Universal Trial Number (UTN)
Trial acronym
SELECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Thromboembolic Pulmonary Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Selexipag
Treatment: Drugs - Placebo

Experimental: Selexipag DB - During the double blind treatment period, participants in this group will receive selexipag. Each participant will start with one oral tablet of selexipag 200 µg in the evening of Day 1 and will continue with 200 µg twice daily (b.i.d.) on Day 2. If this dose is well-tolerated, selexipag is up-titrated with weekly increments of 200 µg until reaching the individual maximal tolerated dose (iMTD) in the range of 200 to 1600 µg b.i.d. The up-titration period up to Week 12 is followed by a stable maintenance treatment period from Week 12 to Week 26, at the iMTD. After Week 26, further up-titration can be allowed (but not above 1600 µg b.i.d.).

Placebo comparator: Placebo DB - During the double-blind treatment period, participants in this group will receive the oral matching placebo, twice daily. A (mock) up-titration scheme will be followed.

Experimental: Selexipag OL - All participants who completed the double-blind treatment period, whether they received placebo or selexipag during the double-blind period, will receive selexipag during the open-label extension period, using the same up-titration schedule as in the double-blind period.


Treatment: Drugs: Selexipag
oral tablets containing 200 µg of selexipag. Depending on the iMTD, participants will receive 1 to 8 tablets at each administration

Treatment: Drugs: Placebo
Oral tablets without active compound
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 20
Timepoint [1] 0 0
Baseline (Day 1, pre-dose), within 2 to 5 hours post-dose on Week 20

Eligibility
Key inclusion criteria
Main

* 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.

Main
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).
* Exclusion criteria related to comorbidities: severe coronary heart disease or unstable angina as assessed by the investigator; mocardial infarction within the last 6 months prior to or during Screening; decompensated cardiac failure if not under close supervision; severe arrhythmias as assessed by the investigator; cerebrovascular events (example transient ischemic attack, stroke) within the last 3 months prior to or during screening; congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension. (PH); known or suspicion of pulmonary veno-occlusive disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/06/2022
Sample size
Target
Accrual to date
Final
128
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Queensland Lung Transplant Service - Chermside
Recruitment hospital [3] 0 0
St Vincent's hospital - Darlinghurst
Recruitment hospital [4] 0 0
Pulmonary Arterial Hypertension Clinic - Hobart
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New Mexico
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Argentina
State/province [19] 0 0
Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
Caba
Country [21] 0 0
Argentina
State/province [21] 0 0
Ciudad Autónoma de Buenos Aires
Country [22] 0 0
Austria
State/province [22] 0 0
Linz
Country [23] 0 0
Austria
State/province [23] 0 0
Vienna
Country [24] 0 0
Belgium
State/province [24] 0 0
Brussels
Country [25] 0 0
Belgium
State/province [25] 0 0
Leuven
Country [26] 0 0
Brazil
State/province [26] 0 0
Belo Horizonte
Country [27] 0 0
Brazil
State/province [27] 0 0
Botucatu
Country [28] 0 0
Brazil
State/province [28] 0 0
Fortaleza
Country [29] 0 0
Brazil
State/province [29] 0 0
Goiania
Country [30] 0 0
Brazil
State/province [30] 0 0
Porto Alegre
Country [31] 0 0
Brazil
State/province [31] 0 0
Santo Andre
Country [32] 0 0
Brazil
State/province [32] 0 0
Sao Paulo
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Pleven
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Sofia
Country [35] 0 0
Canada
State/province [35] 0 0
Alberta
Country [36] 0 0
Canada
State/province [36] 0 0
British Columbia
Country [37] 0 0
Canada
State/province [37] 0 0
Ontario
Country [38] 0 0
Canada
State/province [38] 0 0
Quebec
Country [39] 0 0
China
State/province [39] 0 0
Beijing
Country [40] 0 0
China
State/province [40] 0 0
Guangzhou
Country [41] 0 0
China
State/province [41] 0 0
Shenyang
Country [42] 0 0
China
State/province [42] 0 0
Taiyuan
Country [43] 0 0
China
State/province [43] 0 0
Tian Jin
Country [44] 0 0
Czechia
State/province [44] 0 0
Praha 2
Country [45] 0 0
Denmark
State/province [45] 0 0
Arhus
Country [46] 0 0
Denmark
State/province [46] 0 0
Copenhagen
Country [47] 0 0
Germany
State/province [47] 0 0
Dresden
Country [48] 0 0
Germany
State/province [48] 0 0
Giessen
Country [49] 0 0
Germany
State/province [49] 0 0
Greifswald
Country [50] 0 0
Germany
State/province [50] 0 0
Hamburg
Country [51] 0 0
Germany
State/province [51] 0 0
Hannover
Country [52] 0 0
Germany
State/province [52] 0 0
Heidelberg
Country [53] 0 0
Germany
State/province [53] 0 0
Homburg/Saar
Country [54] 0 0
Germany
State/province [54] 0 0
Leipzig
Country [55] 0 0
Germany
State/province [55] 0 0
Würzburg
Country [56] 0 0
Hungary
State/province [56] 0 0
Budapest
Country [57] 0 0
Hungary
State/province [57] 0 0
Debrecen
Country [58] 0 0
Hungary
State/province [58] 0 0
Pecs
Country [59] 0 0
Hungary
State/province [59] 0 0
Szeged
Country [60] 0 0
Israel
State/province [60] 0 0
Petah Tikva
Country [61] 0 0
Israel
State/province [61] 0 0
Tel-Hashomer
Country [62] 0 0
Italy
State/province [62] 0 0
Bologna
Country [63] 0 0
Italy
State/province [63] 0 0
Pavia
Country [64] 0 0
Italy
State/province [64] 0 0
Roma
Country [65] 0 0
Italy
State/province [65] 0 0
Trieste
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Busan
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Seoul
Country [68] 0 0
Malaysia
State/province [68] 0 0
George Town
Country [69] 0 0
Malaysia
State/province [69] 0 0
Kajang
Country [70] 0 0
Malaysia
State/province [70] 0 0
Kuala Lumpur
Country [71] 0 0
Mexico
State/province [71] 0 0
Ciudad de Mexico
Country [72] 0 0
Mexico
State/province [72] 0 0
Guadalajara
Country [73] 0 0
Mexico
State/province [73] 0 0
Monterrey
Country [74] 0 0
Netherlands
State/province [74] 0 0
Amsterdam
Country [75] 0 0
Netherlands
State/province [75] 0 0
Nieuwegein
Country [76] 0 0
Poland
State/province [76] 0 0
Gdansk
Country [77] 0 0
Poland
State/province [77] 0 0
Krakow
Country [78] 0 0
Poland
State/province [78] 0 0
Lublin
Country [79] 0 0
Poland
State/province [79] 0 0
Otwock
Country [80] 0 0
Poland
State/province [80] 0 0
Poznan
Country [81] 0 0
Poland
State/province [81] 0 0
Szczecin
Country [82] 0 0
Poland
State/province [82] 0 0
Warszawa
Country [83] 0 0
Poland
State/province [83] 0 0
Wroclaw
Country [84] 0 0
Portugal
State/province [84] 0 0
Almada
Country [85] 0 0
Portugal
State/province [85] 0 0
Coimbra
Country [86] 0 0
Portugal
State/province [86] 0 0
Lisbon
Country [87] 0 0
Portugal
State/province [87] 0 0
Porto
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Irkutsk
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Kemerovo
Country [90] 0 0
Russian Federation
State/province [90] 0 0
Moscow
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Novosibirsk
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Saint-Petersburg
Country [93] 0 0
Slovakia
State/province [93] 0 0
Bratislava
Country [94] 0 0
Spain
State/province [94] 0 0
Barcelona
Country [95] 0 0
Spain
State/province [95] 0 0
Madrid
Country [96] 0 0
Spain
State/province [96] 0 0
Santander
Country [97] 0 0
Spain
State/province [97] 0 0
Sevilla
Country [98] 0 0
Spain
State/province [98] 0 0
Valencia
Country [99] 0 0
Sweden
State/province [99] 0 0
Umea
Country [100] 0 0
Sweden
State/province [100] 0 0
Uppsala
Country [101] 0 0
Switzerland
State/province [101] 0 0
Zürich
Country [102] 0 0
Taiwan
State/province [102] 0 0
Kaohsiung
Country [103] 0 0
Taiwan
State/province [103] 0 0
Taichung
Country [104] 0 0
Taiwan
State/province [104] 0 0
Tainan
Country [105] 0 0
Taiwan
State/province [105] 0 0
Taipei
Country [106] 0 0
Thailand
State/province [106] 0 0
Bangkok
Country [107] 0 0
Thailand
State/province [107] 0 0
Khon Kaen
Country [108] 0 0
Turkey
State/province [108] 0 0
Ankara
Country [109] 0 0
Turkey
State/province [109] 0 0
Istanbul
Country [110] 0 0
Turkey
State/province [110] 0 0
Izmir
Country [111] 0 0
Turkey
State/province [111] 0 0
Kartal Istanbul
Country [112] 0 0
Ukraine
State/province [112] 0 0
Dnipro
Country [113] 0 0
Ukraine
State/province [113] 0 0
Kyiv
Country [114] 0 0
Ukraine
State/province [114] 0 0
Lviv
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Cambridge
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Glasgow
Country [117] 0 0
United Kingdom
State/province [117] 0 0
London
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Actelion
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT03689244
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Julian Borissoff, MD, PhD
Address 0 0
Actelion
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03689244