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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: Completed Phase 3 study of Pulmonary Arterial Hypertension, sponsored by Actelion.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-12-04 |
| Est. Completion | 2018-05-29 |
| Phase | Phase 3 |
What the finished NCT03187678 record still lists
NCT03187678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (96% lower).
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 lists 8 locations in 5 states (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.
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Where NCT03187678's enrollment target sits among peer trials
20 49th of 63 higher than 10 of 63 other Pulmonary Arterial Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Arterial Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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