Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03187678 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Pulmonary Arterial Hypertension, sponsored by Actelion.

Completed
Registry status
Phase 3
Development phase
20
Enrollment target
8
Study locations

NCT03187678 is a Phase 3 study of Pulmonary Arterial Hypertension that has completed, run by Actelion. The registered enrollment target is 20 participants, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (96% lower). The trial reports 8 study locations across 5 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03187678, a Phase 3 study of Pulmonary Arterial Hypertension, has completed, sponsored by Actelion.

COMPLETED
Registry status
Phase 3
Development phase
20 participants
Enrollment target
8
Study locations

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

63 total trials

What the Registry Record Tells You About NCT03187678

The ClinicalTrials.gov registry entry for NCT03187678 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (96% lower). The listed sponsor is Actelion, which has 63 total studies on file at ClinicalTrials.gov.

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.

NCT03187678 reports 8 study locations spanning 5 distinct geographic areas - top geographies include Other, California, Massachusetts.

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.

What interventions are being tested in trial NCT03187678?

The interventions under investigation include: i.v. selexipag (DRUG), oral selexipag (Uptravi) (DRUG).

Who is sponsoring clinical trial NCT03187678?

This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Pulmonary Arterial Hypertension

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.