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Prostacyclin Receptor Agonist

Selexipag for Thromboembolic Pulmonary Hypertension (SELECT Trial)

Phase 3
Waitlist Available
Research Sponsored by Actelion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to end of db treatment visit (maximum 59 months)
Awards & highlights

SELECT Trial Summary

This study is evaluating whether a medicine which is used to treat pulmonary arterial hypertension may help treat chronic thromboembolic pulmonary hypertension.

Eligible Conditions
  • Thromboembolic Pulmonary Hypertension

SELECT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to end of db treatment visit (maximum 59 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to end of db treatment visit (maximum 59 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 20
Secondary outcome measures
All-Cause Death or Hospitalizations Related to PH Worsening
Change from Baseline to Week 26 in Borg Dyspnea index or Borg CR10 Scale
Change from baseline to Week 26 in 6-minute walk distance (6MWD)
+4 more

Side effects data

From 2020 Phase 4 trial • 108 Patients • NCT03078907
77%
Headache
53%
Diarrhoea
42%
Nausea
38%
Pain in Jaw
25%
Vomiting
21%
Arthralgia
21%
Pain in Extremity
13%
Dizziness
11%
Dyspepsia
11%
Upper Respiratory Tract Infection
11%
Myalgia
9%
Flushing
9%
Nasopharyngitis
9%
Fatigue
9%
Nasal Congestion
8%
Dyspnoea
8%
Decreased Appetite
8%
Back Pain
6%
Oedema Peripheral
6%
Cough
6%
Epistaxis
4%
Palpitations
4%
Non-Cardiac Chest Pain
4%
Lower Respiratory Tract Infection
4%
Abdominal Pain Upper
4%
Oropharyngeal Pain
4%
Rash
2%
Respiratory Tract Infection
2%
Atrial Flutter
2%
Right Ventricular Failure
2%
Migraine
2%
Abdominal Distension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Selexipag
Placebo

SELECT Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Selexipag OLExperimental Treatment1 Intervention
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.
Group II: Selexipag DBExperimental Treatment1 Intervention
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.).
Group III: Placebo DBPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selexipag
2016
Completed Phase 4
~1750

Find a Location

Who is running the clinical trial?

ActelionLead Sponsor
191 Previous Clinical Trials
35,565 Total Patients Enrolled
Cheryl Lassen, MDStudy DirectorActelion
Julian Borissoff, MD, PhDStudy DirectorActelion

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2019. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03689244.
~20 spots leftby Apr 2025
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