Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension
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|ClinicalTrials.gov Identifier: NCT03187678|
Recruitment Status : Completed
First Posted : June 15, 2017
Results First Posted : May 21, 2019
Last Update Posted : May 21, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: i.v. selexipag Drug: oral selexipag (Uptravi)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label, Single-sequence Cross-over Study to Assess Safety, Tolerability, and Pharmacokinetics of Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension Switching From an Oral Stable Dose of Selexipag|
|Actual Study Start Date :||December 4, 2017|
|Actual Primary Completion Date :||May 29, 2018|
|Actual Study Completion Date :||May 29, 2018|
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
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®.
Other Name: ACT-293987
Drug: oral selexipag (Uptravi)
Uptravi is used as an auxiliary medicinal product, as part of the PAH standard treatment and administered according to the local prescribing information
Other Name: ACT-293987
- Number of Participants With at Least One Adverse Event (AE) [ Time Frame: From Day 1 to Day 37 ]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.
- Number of Participants With Prostacyclin-associated Adverse Events [ Time Frame: From Day 1 to Day 37 ]Prostacyclin-associated AE include headache, diarrhea, nausea, vomiting, jaw pain, myalgia, pain in the extremity, flushing and arthralgia.
- Number of Participants With Adverse Event Related to Injection Site Reactions [ Time Frame: From Day 2 to Day 3 ]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.
- Number of Participants With Prostacyclin-associated AEs Leading to Study Treatment Discontinuation [ Time Frame: From Day 2 to Day 3 ]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).
- Number of Participants With PAH-related Adverse Events [ Time Frame: From Day 1 to Day 37 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187678
|United States, California|
|University of California San Diego Medical center - PULM VASCULAR DIV|
|La Jolla, California, United States, 92037|
|United States, Massachusetts|
|TUFTS New England Medical Center - PULM / CRITICAL CARE & SLEEP|
|Boston, Massachusetts, United States, 02111-1552|
|United States, Ohio|
|Cleveland Clin Foundation - Dept of Pulm & Critical Care Med|
|Cleveland, Ohio, United States, 44195|
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390-8550|
|Universitätsklinikum Giessen und Marburg GmbH, Medizinische Klinik und Poliklinik II, Pneumologie|
|Giessen, Germany, 35392|
|Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin B|
|Greifswald, Germany, 17475|
|Universitätsklinikum Hamburg-Eppendorf, II. Medizinische Klinik und Poliklinik, Pneumologie|
|Hamburg, Germany, 20246|
|Universitätsklinikum Leipzig / Medizinischen Klinik und Poliklinik I, Pneumologie|
|Leipzig, Germany, 04103|
|Study Director:||Ralph Preiss||Actelion|