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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: Completed Phase 4 study of Pulmonary Arterial Hypertension, sponsored by Actelion.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change from baseline to Week 24 of the DLPA activity parameters for daily time spent in non-sedentary activity (NSA) (as defined by Freedson '98 and Koster '16) and daily time spent in moderate-to-vigorous physical activity (MVPA) as defined by Freedson '98 were reported. These variables were assessed by actigraphy and were expressed in minutes. Freedson 1998 established ranges of activity counts obtained from a hip worn accelerometer corresponding to commonly employed MET categories. Based on t
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2017-11-08 |
| Est. Completion | 2020-02-10 |
| Phase | Phase 4 |
What the finished NCT03078907 record still lists
NCT03078907 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (77% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
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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.
Where NCT03078907's enrollment target sits among peer trials
108 17th of 63 higher than 47 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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