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NCT02471183 · ClinicalTrials.gov registry record · Phase 3

Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial Hypertension

A Phase 3 study, sponsored by Actelion.

Completed
Registry status
Phase 3
Development phase
34
Enrollment target

NCT02471183 is a Phase 3 study that has completed, run by Actelion. The registered enrollment target is 34 participants.

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The verdict

NCT02471183, a Phase 3 study, has completed, sponsored by Actelion.

COMPLETED
Registry status
Phase 3
Development phase
34 participants
Enrollment target

Study Summary

This study enrolls patients with pulmonary arterial hypertension (PAH) treated with inhaled treprostinil. During the study, the treatment with inhaled treprostinil will be tapered off and simultaneously replaced with an oral treatment (selexipag) targeting the disease in a similar way. The purpose of the study is i) to investigate the safety and tolerability of oral selexipag in patients who transition from inhaled treprostinil, ii) to investigate the effects of oral selexipag on PAH severity and exercise ability before and after transition, and iii) to gain new information about the patients experience taking oral selexipag compared to inhaled treprostinil. Study participants may stay in the study until the FDA has granted marketing authorization.

Interventions

  • DRUG Selexipag

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2015-10-12
Est. Completion 2016-12-05
Phase Phase 3

Sponsor

Actelion

63 total trials

What the Registry Record Tells You About NCT02471183

The ClinicalTrials.gov registry entry for NCT02471183 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actelion, which has 63 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Selexipag is the first listed.

NCT02471183 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02471183 about?

NCT02471183 is a clinical study titled "Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial Hypertension". This study enrolls patients with pulmonary arterial hypertension (PAH) treated with inhaled treprostinil. During the study, the treatment with inhaled treprostinil will be tapered off and simultaneously replaced with an oral treatment (selexipag) targeting the disease in a similar way. The purpose o...

What is the current status of trial NCT02471183?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 34 participants. The study started on 2015-10-12. Estimated completion is 2016-12-05.

What interventions are being tested in trial NCT02471183?

The interventions under investigation include: Selexipag (DRUG).

Who is sponsoring clinical trial NCT02471183?

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

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.