Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension

NCT03187678 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: AC-065A3092016-004035-21
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 8

Brief Summary

The development of selexipag for intravenous administration will be useful to avoid treatment interruptions in patients with pulmonary arterial hypertension (PAH) already treated with selexipag administered orally as tablets (Uptravi®). The target population for intravenous selexipag includes those PAH patients who are hospitalized and are unable to swallow tablets of Uptravi. The primary objective of this study is to assess whether it is safe for patients with PAH to temporarily change from selexipag tablets (Uptravi®) to selexipag given directly into a vein (intravenous selexipag), and then switching back to the initial oral dose of selexipag.

Conditions

Pulmonary Arterial Hypertension

Keywords

switch; intravenous; selexipag

Outcome Measures

Primary Outcomes (5)

• Number of Participants With at Least One Adverse Event (AE)

  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.

  From Day 1 to Day 37

• Number of Participants With Prostacyclin-associated Adverse Events

  Prostacyclin-associated AE include headache, diarrhea, nausea, vomiting, jaw pain, myalgia, pain in the extremity, flushing and arthralgia.

  From Day 1 to Day 37

• Number of Participants With Adverse Event Related to Injection Site Reactions

  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.

  From Day 2 to Day 3

• Number of Participants With Prostacyclin-associated AEs Leading to Study Treatment Discontinuation

  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).

  From Day 2 to Day 3

• Number of Participants With PAH-related Adverse Events

  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.

  From Day 1 to Day 37

Study Arms (1)

Selexipag

EXPERIMENTAL

Subjects with stable pulmonary arterial hypertension (PAH) and currently treated with a stable oral dose of Uptravi will be switched to i.v. selexipag from Day 2 to Day 3 (2 infusions on Day 2 and 1 infusion on Day 3). Otherwise, they will continue with their current oral selexipag treatment throughout the study.

Drug: i.v. selexipag; Drug: oral selexipag (Uptravi)

Interventions

i.v. selexipag DRUG

Selexipag for intravenous administration, twice daily as an infusion over 87 min. The dose is individualized for each subject to correspond to his/her current oral dose of Uptravi®.

Also known as: ACT-293987

Selexipag

oral selexipag (Uptravi) DRUG

Uptravi is used as an auxiliary medicinal product, as part of the PAH standard treatment and administered according to the local prescribing information

Also known as: ACT-293987

Selexipag

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form prior to any study-mandated procedure.
• Male and female subjects aged from 18 to 75 years (inclusive),
• Subjects with stable pulmonary arterial hypertension (PAH) defined as WHO Functional Class I-III at Visit 1 and Visit 2, and no change (i.e., introduction or dose change) in PAH-specific medication (i.e., ERA, PDE-5 inhibitor or sGC stimulator) and diuretics in the last 28 days prior to Visit 2.
• Subjects currently treated with Uptravi® at a stable dose (i.e. unchanged dose) for at least 28 days before Visit 2.
• Women of childbearing potential must have a negative pregnancy test at Visit 1 (screening) and Visit 2.

You may not qualify if:

• Pregnant, planning to become pregnant or lactating.
• Known and documented moderate or severe hepatic impairment.
• Subjects having received gemfibrozil at any time since initiation of Uptravi®.
• Treatment with any prostacyclin and prostacyclin analogs within 28 days prior to Visit 1.
• SBP \< 90 mmHg at Visit 1 or at Visit 2.
• Known or suspected uncontrolled hyperthyroidism.
• Severe renal failure and ongoing or planned dialysis.
• Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results.
• Known concomitant life-threatening disease with a life expectancy \< 12 months.
• Treatment with another investigational treatment within 3 months of Visit 1.

Sponsors & Collaborators

• Actelion: lead

Study Sites (8)

University of California San Diego Medical center - PULM VASCULAR DIV

La Jolla, California, 92037, United States

Location

TUFTS New England Medical Center - PULM / CRITICAL CARE & SLEEP

Boston, Massachusetts, 02111-1552, United States

Location

Cleveland Clin Foundation - Dept of Pulm & Critical Care Med

Cleveland, Ohio, 44195, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8550, United States

Location

Universitätsklinikum Giessen und Marburg GmbH, Medizinische Klinik und Poliklinik II, Pneumologie

Giessen, 35392, Germany

Location

Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin B

Greifswald, 17475, Germany

Location

Universitätsklinikum Hamburg-Eppendorf, II. Medizinische Klinik und Poliklinik, Pneumologie

Hamburg, 20246, Germany

Location

Universitätsklinikum Leipzig / Medizinischen Klinik und Poliklinik I, Pneumologie

Leipzig, 04103, Germany

Location

Related Publications (1)

• Klose H, Chin KM, Ewert R, Gall H, Parambil J, Poch D, Seyfarth HJ, Axelsen LN, Hsu Schmitz SF, Stein C, Preston IR. Temporarily switching from oral to intravenous selexipag in patients with pulmonary arterial hypertension: safety, tolerability, and pharmacokinetic results from an open-label, phase III study. Respir Res. 2021 Feb 3;22(1):34. doi: 10.1186/s12931-020-01594-8.

  PMID: 33536021 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

selexipag

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: clinical trial disclosure desk
• Organization: Actelion Pharmaceuticals Ltd

clinical-trials-disclosure@its.jnj.com

0041615656565

Study Officials

• Ralph Preiss

  Actelion

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 15, 2017
• Study Start: December 4, 2017
• Primary Completion: May 29, 2018
• Study Completion: May 29, 2018
• Last Updated: June 29, 2025
• Results First Posted: May 21, 2019

Record last verified: 2025-06

Locations

DE (4); US (4)