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COMPLETED Phase 3

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

NCT03187678 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG i.v. selexipag
  • DRUG oral selexipag (Uptravi)

Study Locations (8)

Other

  • Universitätsklinikum Giessen und Marburg GmbH, Medizinische Klinik und Poliklinik II, Pneumologie — Giessen
  • Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin B — Greifswald
  • Universitätsklinikum Hamburg-Eppendorf, II. Medizinische Klinik und Poliklinik, Pneumologie — Hamburg
  • Universitätsklinikum Leipzig / Medizinischen Klinik und Poliklinik I, Pneumologie — Leipzig

California

  • University of California San Diego Medical center - PULM VASCULAR DIV — La Jolla

Massachusetts

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

Ohio

  • Cleveland Clin Foundation - Dept of Pulm & Critical Care Med — Cleveland

Texas

  • University of Texas Southwestern Medical Center — Dallas

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2017-12-04
Est. Completion 2018-05-29
Phase Phase 3

Sponsor

Actelion

14 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03187678

The ClinicalTrials.gov registry entry for NCT03187678 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actelion, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 2 interventions — of which i.v. selexipag is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03187678 reports 8 study locations spanning 5 distinct geographic areas — top geographies include Other, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03187678 about?

NCT03187678 is a clinical study titled "Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension". 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 ...

What is the current status of trial NCT03187678?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2017-12-04. Estimated completion is 2018-05-29.

What conditions does trial NCT03187678 study?

This clinical trial studies the following conditions: Pulmonary Arterial Hypertension. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03187678?

The interventions under investigation include: i.v. selexipag (DRUG), oral selexipag (Uptravi) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03187678?

This trial is sponsored by Actelion, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03187678 being conducted?

This trial has 8 study locations across California, Massachusetts, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial