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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
Sponsor:
Information provided by (Responsible Party):
Actelion

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.


Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: i.v. selexipag Drug: oral selexipag (Uptravi) Phase 3

Detailed Description:
After screening (Visit 1), each subject will participate in the following consecutive treatment periods: Period 1(treatment with oral selexipag at Visit 2/Day 1), Period 2 (treatment with intravenous selexipag at Visit 2/ Day 2 and Day 3), Period 3 (treatment with oral selexipag starting in the evening of Visit 2/Day 3 and ending 7 to 11 days later at Visit 3). Then a safety follow-up period is planned up to end of study visit (EOS), which occurs between Day 33 and Day 40.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Selexipag
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Locations
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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
Germany
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
Sponsors and Collaborators
Actelion
Investigators
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Study Director: Ralph Preiss Actelion
  Study Documents (Full-Text)

Documents provided by Actelion:
Study Protocol  [PDF] January 27, 2017
Statistical Analysis Plan  [PDF] July 2, 2018


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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT03187678     History of Changes
Other Study ID Numbers: AC-065A309
2016-004035-21 ( EudraCT Number )
First Posted: June 15, 2017    Key Record Dates
Results First Posted: May 21, 2019
Last Update Posted: May 21, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Actelion:
switch
intravenous
selexipag

Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Selexipag
Antihypertensive Agents