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NCT02558231 · ClinicalTrials.gov registry record · Phase 3
The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension
A Phase 3 study of Pulmonary Arterial Hypertension, sponsored by Actelion.
- Completed
- Registry status
- Phase 3
- Development phase
- 247
- Enrollment target
- 20
- Study locations
NCT02558231 is a Phase 3 study of Pulmonary Arterial Hypertension that has completed, run by Actelion. The registered enrollment target is 247 participants, below the 458-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT02558231, a Phase 3 study of Pulmonary Arterial Hypertension, has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 247 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension.
Conditions Studied
Interventions
- DRUG Tadalafil
- DRUG Selexipag
- DRUG Macitentan
Study Locations (20)
California
- UCSD Health Sciences - La Jolla
- UCLA Medical Center - Los Angeles
Florida
- Mayo Clinic Jacksonville - Jacksonville
- Cleveland Clinic Florida - Weston
Massachusetts
- Tufts Medical Center - Boston
- Boston University Medical Center - Boston
Pennsylvania
- Allegheny General Hospital of Research - Pittsburgh
- UPMC Presbyterian - Pittsburgh
Texas
- University of Texas Southwestern Medical Center - Dallas
- Houston Methodist Hospital - Houston
Arizona
- Arizona Pulmonary Specialists, LTD - Phoenix
Georgia
- Piedmont Pulmonary and Critical Care Research - Atlanta
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 247 participants |
| Start Date | 2016-05-01 |
| Est. Completion | 2020-04-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02558231
The ClinicalTrials.gov registry entry for NCT02558231 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 247 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 458-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (46% 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 3 interventions - of which Tadalafil is the first listed.
NCT02558231 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02558231 about?
NCT02558231 is a clinical study titled "The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension". The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arteria...
What is the current status of trial NCT02558231?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 247 participants. The study started on 2016-05-01. Estimated completion is 2020-04-20.
What conditions does trial NCT02558231 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.
What interventions are being tested in trial NCT02558231?
The interventions under investigation include: Tadalafil (DRUG), Selexipag (DRUG), Macitentan (DRUG).
Who is sponsoring clinical trial NCT02558231?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02558231 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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