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NCT03078907 · ClinicalTrials.gov registry record · Phase 4

Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.

A Phase 4 study of Pulmonary Arterial Hypertension, sponsored by Actelion.

Completed
Registry status
Phase 4
Development phase
108
Enrollment target
20
Study locations

NCT03078907 is a Phase 4 study of Pulmonary Arterial Hypertension that has completed, run by Actelion. The registered enrollment target is 108 participants, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT03078907, a Phase 4 study of Pulmonary Arterial Hypertension, has completed, sponsored by Actelion.

COMPLETED
Registry status
Phase 4
Development phase
108 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of this study is to evaluate the effect of selexipag on the physical activity of patients with pulmonary arterial hypertension (PAH) in their daily life, by using a wearable wrist device (actigraph). The actigraph will collect data on daily life physical activity in the patient's real environment. In addition, the PAH symptoms and their impacts will be assessed by using an electronic patient reported outcome measure in the patient's real environment. Patients will be assigned randomly to either selexipag or placebo.

Interventions

  • DRUG Placebo
  • DRUG Selexipag

Study Locations (20)

Other

  • Medizinische Universität Innsbruck (MUI), Abt. für Pneumologie, Haus 2 - Innsbruck
  • Krankenhaus der Elisabethinen, Servicestelle Klinische Studien - Linz
  • Hôpital Bicêtre, ervice de Pneumologie et Réanimation respiratoire - Le Kremlin-Bicêtre
  • CHRU de Lille - Hôpital Albert Calmette, Service de cardiologie - Lille
  • Hospital Larrey CHU de Toulouse - Toulouse

North Carolina

  • UNC Pulmonary Speciality Clinic - Chapel Hill
  • Duke University School of Medicine, Duke Pulmonary Vascular Disease center - Durham

Ohio

  • University of Cincinnati, Heart, Lung and Vascular Institute - Cincinnati
  • CCF- Akron General Medical Hospital - Cleveland

Texas

  • Methodist Clinical Trials - San Antonio
  • University of Texas Health Science Center (San Antonio) - San Antonio

California

  • LA Biomedical Research Institute - Torrance

Georgia

  • Northside Hospital - Atlanta

Kentucky

  • Kentuckiana Pulmonary Research Center - Louisville

Massachusetts

  • Tufts Medical Center, Pulmonary/Critical Care & Sleep - Boston

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2017-11-08
Est. Completion 2020-02-10
Phase Phase 4

Sponsor

Actelion

63 total trials

What the Registry Record Tells You About NCT03078907

The ClinicalTrials.gov registry entry for NCT03078907 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (77% 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 Placebo is the first listed.

NCT03078907 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, North Carolina, Ohio.

Frequently Asked Questions

What is clinical trial NCT03078907 about?

NCT03078907 is a clinical study titled "Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.". The primary objective of this study is to evaluate the effect of selexipag on the physical activity of patients with pulmonary arterial hypertension (PAH) in their daily life, by using a wearable wrist device (actigraph). The actigraph will collect data on daily life physical activity in the patient...

What is the current status of trial NCT03078907?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 108 participants. The study started on 2017-11-08. Estimated completion is 2020-02-10.

What conditions does trial NCT03078907 study?

This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.

What interventions are being tested in trial NCT03078907?

The interventions under investigation include: Placebo (DRUG), Selexipag (DRUG).

Who is sponsoring clinical trial NCT03078907?

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

Where is trial NCT03078907 being conducted?

This trial has 20 study locations across California, Georgia, Kentucky, Massachusetts, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.