Trial Outcomes & Findings for Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension (NCT NCT03187678)
NCT ID: NCT03187678
Last Updated: 2025-06-29
Results Overview
AE is any untoward medical event that occurs in a participant during the course of the study whether or not considered by the investigator as related to the study treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
20 participants
Primary outcome timeframe
From Day 1 to Day 37
Results posted on
2025-06-29
Participant Flow
Twenty-two patients treated with Uptravi for pulmonary arterial hypertension (PAH) were screened; 20 of them were enrolled in the study.
Participant milestones
| Measure |
Selexipag
Subjects treated with a stable dose of oral selexipag (Uptravi) between 200 and 1600 ug twice daily continued to take Uptravi at their prescribed dose during Period 1 (Day 1), then they were switched to intravenous (iv) selexipag during period 2 (3 doses, Day 2 \& Day 3) and back to Uptravi during Period 3
|
|---|---|
|
Period 1 (Oral Selexipag)
STARTED
|
20
|
|
Period 1 (Oral Selexipag)
COMPLETED
|
20
|
|
Period 1 (Oral Selexipag)
NOT COMPLETED
|
0
|
|
Period 2 (Intravenous Selexipag)
STARTED
|
20
|
|
Period 2 (Intravenous Selexipag)
COMPLETED
|
20
|
|
Period 2 (Intravenous Selexipag)
NOT COMPLETED
|
0
|
|
Period 3 (Oral Selexipag)
STARTED
|
20
|
|
Period 3 (Oral Selexipag)
COMPLETED
|
20
|
|
Period 3 (Oral Selexipag)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension
Baseline characteristics by cohort
| Measure |
Selexipag
n=20 Participants
Subjects treated with a stable dose of oral selexipag (Uptravi) between 200 and 1600 ug twice daily continued to take Uptravi at their prescribed dose during Period 1 (Day 1), then they were switched to intravenous (iv) selexipag during period 2 (3 doses, Day 2 \& Day 3) and back to Uptravi during Period 3
|
|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 9.43 • n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
13 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=99 Participants
|
|
World Health Organization Functional classes (WHO FC)
FC I
|
1 Participants
n=99 Participants
|
|
World Health Organization Functional classes (WHO FC)
FC II
|
13 Participants
n=99 Participants
|
|
World Health Organization Functional classes (WHO FC)
FC III
|
6 Participants
n=99 Participants
|
|
Uptravi dose at screening
200 ug twice daily
|
0 Participants
n=99 Participants
|
|
Uptravi dose at screening
400 ug twice daily
|
1 Participants
n=99 Participants
|
|
Uptravi dose at screening
600 ug twice daily
|
2 Participants
n=99 Participants
|
|
Uptravi dose at screening
800 ug twice daily
|
2 Participants
n=99 Participants
|
|
Uptravi dose at screening
1000 ug twice daily
|
3 Participants
n=99 Participants
|
|
Uptravi dose at screening
1200 ug twice daily
|
2 Participants
n=99 Participants
|
|
Uptravi dose at screening
1400 ug twice daily
|
1 Participants
n=99 Participants
|
|
Uptravi dose at screening
1600 ug twice daily
|
9 Participants
n=99 Participants
|
|
PAH-specific therapies at baseline
PDE-5 inhibitors
|
1 Participants
n=99 Participants
|
|
PAH-specific therapies at baseline
sGC stimulator
|
1 Participants
n=99 Participants
|
|
PAH-specific therapies at baseline
ERA + PDE5-inhibitors
|
13 Participants
n=99 Participants
|
|
PAH-specific therapies at baseline
ERA + sGC stimulator
|
5 Participants
n=99 Participants
|
|
PAH etiology at baseline
Idiopathic PAH
|
13 Participants
n=99 Participants
|
|
PAH etiology at baseline
Heritable PAH
|
1 Participants
n=99 Participants
|
|
PAH etiology at baseline
Drug or toxin induced PAH
|
0 Participants
n=99 Participants
|
|
PAH etiology at baseline
Associated with CTD
|
4 Participants
n=99 Participants
|
|
PAH etiology at baseline
Associated with CHD
|
1 Participants
n=99 Participants
|
|
PAH etiology at baseline
Associated with HIV
|
0 Participants
n=99 Participants
|
|
PAH etiology at baseline
Associated with portal hypertension
|
1 Participants
n=99 Participants
|
|
PAH etiology at baseline
Associated with schistosomiasis
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 37Population: Safety analysis set including all enrolled subjects who received at least one dose of Uptravi or intravenous selexipag during any of the study periods
AE is any untoward medical event that occurs in a participant during the course of the study whether or not considered by the investigator as related to the study treatment.
Outcome measures
| Measure |
Selexipag
n=20 Participants
Subjects treated with a stable dose of oral selexipag (Uptravi) between 200 and 1600 ug twice daily continued to take Uptravi at their prescribed dose during Period 1 (Day 1), then they were switched to intravenous (iv) selexipag during period 2 (3 doses, Day 2 \& Day 3) and back to Uptravi during Period 3
|
|---|---|
|
Number of Participants With at Least One Adverse Event (AE)
|
15 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 37Population: Safety analysis set including all enrolled subjects who received at least one dose of Uptravi or intravenous selexipag during any of the study periods
Prostacyclin-associated AE include headache, diarrhea, nausea, vomiting, jaw pain, myalgia, pain in the extremity, flushing and arthralgia.
Outcome measures
| Measure |
Selexipag
n=20 Participants
Subjects treated with a stable dose of oral selexipag (Uptravi) between 200 and 1600 ug twice daily continued to take Uptravi at their prescribed dose during Period 1 (Day 1), then they were switched to intravenous (iv) selexipag during period 2 (3 doses, Day 2 \& Day 3) and back to Uptravi during Period 3
|
|---|---|
|
Number of Participants With Prostacyclin-associated Adverse Events
|
7 Participants
|
PRIMARY outcome
Timeframe: From Day 2 to Day 3Population: iv safety analysis set including all enrolled subjects who received at least one dose of intravenous selexipag during Period 2
This is the number of participants with at least one clinically significant reaction at the injection site (e.g., erythema/redness, tenderness, swelling, induration, hemorrhage at the injection site) occurring on the days of intravenous (iv) selexipag injection.
Outcome measures
| Measure |
Selexipag
n=20 Participants
Subjects treated with a stable dose of oral selexipag (Uptravi) between 200 and 1600 ug twice daily continued to take Uptravi at their prescribed dose during Period 1 (Day 1), then they were switched to intravenous (iv) selexipag during period 2 (3 doses, Day 2 \& Day 3) and back to Uptravi during Period 3
|
|---|---|
|
Number of Participants With Adverse Event Related to Injection Site Reactions
|
2 Participants
|
PRIMARY outcome
Timeframe: From Day 2 to Day 3Population: iv safety analysis set including all enrolled subjects who received at least one dose of intravenous selexipag during period 2
This is the number of subjects who discontinued the i.v. selexipag treatment due to prostacyclin-associated adverse events (headache, diarrhea, nausea, vomiting, jaw pain, myalgia, pain in the extremity, flushing and arthralgia).
Outcome measures
| Measure |
Selexipag
n=20 Participants
Subjects treated with a stable dose of oral selexipag (Uptravi) between 200 and 1600 ug twice daily continued to take Uptravi at their prescribed dose during Period 1 (Day 1), then they were switched to intravenous (iv) selexipag during period 2 (3 doses, Day 2 \& Day 3) and back to Uptravi during Period 3
|
|---|---|
|
Number of Participants With Prostacyclin-associated AEs Leading to Study Treatment Discontinuation
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 37Population: Safety analysis set including all enrolled subjects who received at least one dose of Uptravi or intravenous selexipag during any of the study periods
This is the number of participants with at least one AE considered to be related to pulmonary arterial hypertension during the course of the study.
Outcome measures
| Measure |
Selexipag
n=20 Participants
Subjects treated with a stable dose of oral selexipag (Uptravi) between 200 and 1600 ug twice daily continued to take Uptravi at their prescribed dose during Period 1 (Day 1), then they were switched to intravenous (iv) selexipag during period 2 (3 doses, Day 2 \& Day 3) and back to Uptravi during Period 3
|
|---|---|
|
Number of Participants With PAH-related Adverse Events
|
3 Participants
|
Adverse Events
Selexipag
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Selexipag
n=20 participants at risk
Subjects treated with a stable dose of oral selexipag (Uptravi) between 200 and 1600 ug twice daily continued to take Uptravi at their prescribed dose during Period 1 (Day 1), then they were switched to intravenous (iv) selexipag during period 2 (3 doses, Day 2 \& Day 3) and back to Uptravi during Period 3
|
|---|---|
|
Cardiac disorders
Right Ventricular Failure
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Eye disorders
Blindness Unilateral
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Eye disorders
Rhegmatogenous Retinal Detachment
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
Other adverse events
| Measure |
Selexipag
n=20 participants at risk
Subjects treated with a stable dose of oral selexipag (Uptravi) between 200 and 1600 ug twice daily continued to take Uptravi at their prescribed dose during Period 1 (Day 1), then they were switched to intravenous (iv) selexipag during period 2 (3 doses, Day 2 \& Day 3) and back to Uptravi during Period 3
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20 • Number of events 2 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 2 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Number of events 3 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Number of events 2 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
General disorders
Infusion Site Erythema
|
10.0%
2/20 • Number of events 3 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
General disorders
Infusion Site Swelling
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
General disorders
Oedema Peripheral
|
10.0%
2/20 • Number of events 2 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Injury, poisoning and procedural complications
Incorrect Drug Administration Rate
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Nervous system disorders
Dysgeusia
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Nervous system disorders
Headache
|
20.0%
4/20 • Number of events 9 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Nervous system disorders
Tension Headache
|
5.0%
1/20 • Number of events 2 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Renal and urinary disorders
Chromaturia
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.0%
1/20 • Number of events 1 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
|
Vascular disorders
Flushing
|
10.0%
2/20 • Number of events 2 • From Day 2 to Day 37
Treatment-emergent AEs are reported, i.e. serious and non-serious AEs starting on or after the intravenous injection of selexipag, which is the investigational treatment.
|
Additional Information
clinical trial disclosure desk
Actelion Pharmaceuticals Ltd
Phone: 0041615656565
Email: [email protected]
Results disclosure agreements
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Restriction type: OTHER